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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1141-2177 | Other Identifier | World Health Organization |
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The purpose of this study is to determine whether ketamine-induced brain activity changes are modulated by TAK-063 administration using neuroimaging battery tests.
The drug being tested in this study is called TAK-063. This study will look at brain activity changes and treatment of psychotic-like symptoms induced by ketamine, in people who take TAK-063.
The study will enroll approximately 27 participants. Participants will be randomly assigned to one of treatment sequences-which will remain undisclosed to the participants during the study (unless there is an urgent medical need). Participants will receive the following study medications by the end of the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Placebo + TAK-063 3 mg + TAK-063 30 mg | Experimental | Period 1, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 3 milligram (mg), orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 30 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 & 2 are followed by 7 day washout period. |
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| Sequence 2: TAK-063 3 mg + TAK-063 30 mg + Placebo | Experimental | Period 1, Day 1: TAK-063 3 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 30 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 & 2 are followed by 7 day washout period. |
|
| Sequence 3: TAK-063 30 mg + Placebo + TAK-063 3 mg | Experimental | Period 1, Day 1: TAK-063 30 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 3 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 & 2 are followed by 7 day washout period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine intravenous administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ketamine-Induced Brain Activity in Regions of Interest During Resting State | Ketamine model was used to enhance the sensitivity to detect an effect of phosphodiesterase 10a (PDE10a) inhibition by TAK-063 by ketamine using neuroimaging battery tests. Ketamine induced robust blood oxygen level-dependent(BOLD) functional magnetic resonance imaging(fMRI) response while maintaining minimal accompanying psychotomimetic symptoms. The regions of interest include:left anterior cingulate cortex,right anterior cingulate cortex,left posterior cingulate cortex,right posterior cingulate cortex,left striatum,right striatum,left amygdala,right amygdala,left substantia nigra,right substantia nigra,left thalamus,right thalamus,left ventrolateral prefrontal cortex,right ventrolateral prefrontal cortex,left dorsolateral prefrontal cortex,right dorsolateral prefrontal cortex,left hippocampus,right hippocampus,left subgenual cingulate/Ba25,right subgenual cingulate/Ba25,left paracingulate gyrus/Ba32, and right paracingulate gyrus/Ba32. | Day 1: 4 hours post TAK-063 dose or placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite (M-I) | Day 1: pre-dose and at multiple time points (up to 24 hours) postdose | |
| Tmax: Time to Reach Cmax for TAK-063 and TAK-063 M-I | Day 1: pre-dose and at multiple time points (up to 24 hours) postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda Development Center Americas, Inc. (Note: This product was divested to Axsome in 2026) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Brain Institute, University of Utah | Salt Lake City | Utah | 84108 | United States |
Healthy male participants were enrolled in this 3 period study and randomized in 1 of 9 administration sequences to receive TAK-063 3 mg, TAK-063 10 mg, TAK-063 30 mg and TAK-063 matching placebo. Due to predicted exposures being higher than likely clinically relevant, the dose of 300 mg was removed and replaced by 10 mg in protocol amendment 3.
Participants took part in the study at 1 investigative site in the United States from 27 June 2013 to 28 August 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + TAK-063 3 mg + TAK-063 30 mg | TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention Period (1 Day) |
|
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| Sequence 4: Placebo + TAK-063 3 mg + TAK-063 300 mg | Experimental | Period 1, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 3 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 & 2 are followed by 7 day washout period. |
|
| Sequence 5: TAK-063 3 mg + TAK-063 300 mg+ Placebo | Experimental | Period 1, Day 1: TAK-063 3 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 & 2 are followed by 7 day washout period |
|
| Sequence 6: TAK-063 300 mg + Placebo + TAK-063 3 mg | Experimental | Period 1, Day 1: TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 3 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 & 2 are followed by 7 day washout period. |
|
| Sequence 7: Placebo + TAK-063 30 mg + TAK-063 300 mg | Experimental | Period 1, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight: Period 2, Day 1: TAK-063 30 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 & 2 are followed by 7 day washout period |
|
| Sequence 8: TAK-063 30 mg + TAK-063 300 mg + Placebo | Experimental | Period 1, Day 1: TAK-063 30 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 & 2 are followed by 7 day washout period. |
|
| Sequence 9: TAK-063 300 mg + Placebo + TAK-063 30 mg | Experimental | Period 1, Day 1: TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 30 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 & 2 are followed by 7 day washout period |
|
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| TAK-063 | Drug | TAK-063 tablets |
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| TAK-063 Placebo | Drug | TAK-063 placebo-matching tablets |
|
| AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 M-I | Day 1: Pre-dose and at multiple time points (up to 24 hours) post-dose |
| Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | Baseline up to 14 days after last dose of study drug (Day 32) |
| Percentage of Participants Who Meet the Takeda Global Research and Development Center, Inc. (TGRD) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | The percentage of participants with any markedly abnormal standard safety laboratory values collected throughout study. | Baseline up to 14 days after last dose of study drug (Day 32) |
| Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | The percentage of participants who meet markedly abnormal criteria designated by TGRD. Vital signs included oral temperature, respiration, blood pressure and pulse (beats per minute). | Baseline up to 14 days after last dose of study drug (Day 32) |
| Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose | The percentage of participants who meet markedly abnormal criteria designated by TGRD measured throughout study. | Baseline up to 14 days after last dose of study drug (Day 32) |
| FG001 | TAK-063 3 mg + TAK-063 30 mg + Placebo | TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| FG002 | TAK-063 30 mg + Placebo + TAK-063 3 mg | TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| FG003 | Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg | TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| FG004 | TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo | TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| FG005 | TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg | TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| FG006 | Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg | TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| FG007 | TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo | TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| FG008 | TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg | TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| COMPLETED |
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| NOT COMPLETED |
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| Washout Period 1 (7 Days) |
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| Second Intervention Period (1 Day) |
|
| Washout Period 2 (7 Days) |
|
| Third Intervention Period (1 Day) |
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Randomized set included all participants who were randomized to either 1 of the 9 treatment sequences.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + TAK-063 3 mg + TAK-063 30 mg | TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| BG001 | TAK-063 3 mg + TAK-063 30 mg + Placebo | TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| BG002 | TAK-063 30 mg + Placebo + TAK-063 3 mg | TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| BG003 | Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg | TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| BG004 | TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo | TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| BG005 | TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg | TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| BG006 | Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg | TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| BG007 | TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo | TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| BG008 | TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg | TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | centimeters (cm) |
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| Weight | Mean | Standard Deviation | kilogram (kg) |
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| Body Mass Index | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
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| Smoking Classification | Number | participants |
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| Caffeine Consumption | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ketamine-Induced Brain Activity in Regions of Interest During Resting State | Ketamine model was used to enhance the sensitivity to detect an effect of phosphodiesterase 10a (PDE10a) inhibition by TAK-063 by ketamine using neuroimaging battery tests. Ketamine induced robust blood oxygen level-dependent(BOLD) functional magnetic resonance imaging(fMRI) response while maintaining minimal accompanying psychotomimetic symptoms. The regions of interest include:left anterior cingulate cortex,right anterior cingulate cortex,left posterior cingulate cortex,right posterior cingulate cortex,left striatum,right striatum,left amygdala,right amygdala,left substantia nigra,right substantia nigra,left thalamus,right thalamus,left ventrolateral prefrontal cortex,right ventrolateral prefrontal cortex,left dorsolateral prefrontal cortex,right dorsolateral prefrontal cortex,left hippocampus,right hippocampus,left subgenual cingulate/Ba25,right subgenual cingulate/Ba25,left paracingulate gyrus/Ba32, and right paracingulate gyrus/Ba32. | The pharmacodynamic (PD) analysis set included all participants in the safety set and with at least 1 valid PD assessment. PD analysis set did not include 2 participants treated with TAK-063 300 mg. | Posted | Mean | Standard Deviation | percent signal change in brain activity | Day 1: 4 hours post TAK-063 dose or placebo |
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| Secondary | Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite (M-I) | The pharmacokinetic (PK) analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1: pre-dose and at multiple time points (up to 24 hours) postdose |
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| Secondary | Tmax: Time to Reach Cmax for TAK-063 and TAK-063 M-I | The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg. | Posted | Median | Full Range | hours | Day 1: pre-dose and at multiple time points (up to 24 hours) postdose |
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| Secondary | AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 M-I | The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg. | Posted | Mean | Standard Deviation | nanogram hours per milliliter (ng*hr/mL) | Day 1: Pre-dose and at multiple time points (up to 24 hours) post-dose |
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| Secondary | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Baseline up to 14 days after last dose of study drug (Day 32) |
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| Secondary | Percentage of Participants Who Meet the Takeda Global Research and Development Center, Inc. (TGRD) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | The percentage of participants with any markedly abnormal standard safety laboratory values collected throughout study. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Baseline up to 14 days after last dose of study drug (Day 32) |
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| Secondary | Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | The percentage of participants who meet markedly abnormal criteria designated by TGRD. Vital signs included oral temperature, respiration, blood pressure and pulse (beats per minute). | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Baseline up to 14 days after last dose of study drug (Day 32) |
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| Secondary | Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose | The percentage of participants who meet markedly abnormal criteria designated by TGRD measured throughout study. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Baseline up to 14 days after last dose of study drug (Day 32) |
|
Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3. | 0 | 22 | 15 | 22 | ||
| EG001 | TAK-063 3 mg | TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3. | 0 | 14 | 7 | 14 | ||
| EG002 | TAK-063 10 mg | TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3. | 0 | 14 | 8 | 14 | ||
| EG003 | TAK-063 30 mg | TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3. | 0 | 15 | 13 | 15 | ||
| EG004 | TAK-063 300 mg | TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3. | 0 | 2 | 2 | 2 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diplopia | Eye disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (V 17.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (V 17.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Muscle Tightness | Musculoskeletal and connective tissue disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Coordination Abnormal | Nervous system disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Communication Disorder | Psychiatric disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA (V 17.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (V 17.0) | Systematic Assessment |
|
No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda (Note: This product was divested to Axsome in 2026) | +1-877-825-3327 | trialdisclosures@takeda.com |
| ID | Term |
|---|---|
| D007649 | Ketamine |
| C000594749 | 1-(2-fluoro-4-(1H-pyrazol-1-yl)phenyl)-5-methoxy-3-(1-phenyl-1H-pyrazol-5-yl)pyridazin-4(1H)-one |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Withdrawal by Subject |
|
| Noncompliance, Irritability |
|
| Male |
|
| Non Hispanic or Latino |
|
| Asian |
|
| Multiracial |
|
| Pacific Islander-White |
|
| Ex-smoker |
|
| Not consumes Caffiene |
|
| Right Anterior Cingulate Cortex |
|
| Left Posterior Cingulate Cortex |
|
| Right Posterior Cingulate Cortex |
|
| Left Striatum |
|
| Right Striatum |
|
| Left Amygdala |
|
| Right Amygdala |
|
| Left Substantia Nigra |
|
| Right Substantia Nigra |
|
| Left Thalamus |
|
| Right Thalamus |
|
| Left Ventrolateral Prefrontal Cortex |
|
| Right Ventrolateral Prefrontal Cortex |
|
| Left Dorsolateral Prefrontal Cortex |
|
| Right Dorsolateral Prefrontal Cortex |
|
| Left Hippocampus |
|
| Right Hippocampus |
|
| Left Subgenual Cingulate/BA25 |
|
| Right Subgenual Cingulate/BA25 |
|
| Left Paracingulate Gyrus/BA32 |
|
| Right Paracingulate Gyrus/BA32 |
|
| Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.869 | LS Mean Difference | -0.0367 | Standard Error of the Mean | 0.22075 | 2-Sided | 95 | -0.4853 | 0.4119 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.306 | LS Mean Difference | -0.2180 | Standard Error of the Mean | 0.20968 | 2-Sided | 95 | -0.6441 | 0.2081 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.169 | LS Mean Difference | -0.2525 | Standard Error of the Mean | 0.17956 | 2-Sided | 95 | -0.6174 | 0.1124 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.831 | LS Mean Difference | -0.0417 | Standard Error of the Mean | 0.19375 | 2-Sided | 95 | -0.4354 | 0.3521 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.197 | LS Mean Difference | -0.2421 | Standard Error of the Mean | 0.18403 | 2-Sided | 95 | -0.6161 | 0.1319 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.480 | LS Mean Difference | -0.1155 | Standard Error of the Mean | 0.16180 | 2-Sided | 95 | -0.4443 | 0.2133 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.345 | LS Mean Difference | 0.1673 | Standard Error of the Mean | 0.17458 | 2-Sided | 95 | -0.1875 | 0.5221 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.371 | LS Mean Difference | -0.1504 | Standard Error of the Mean | 0.16583 | 2-Sided | 95 | -0.4874 | 0.1866 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.364 | LS Mean Difference | -0.1731 | Standard Error of the Mean | 0.18808 | 2-Sided | 95 | -0.5553 | 0.2092 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.507 | LS Mean Difference | 0.1362 | Standard Error of the Mean | 0.20294 | 2-Sided | 95 | -0.2762 | 0.5486 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.210 | LS Mean Difference | -0.2464 | Standard Error of the Mean | 0.19276 | 2-Sided | 95 | -0.6381 | 0.1453 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.039 | LS Mean Difference | -0.3059 | Standard Error of the Mean | 0.14253 | 2-Sided | 95 | -0.5955 | -0.0162 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.931 | LS Mean Difference | 0.0134 | Standard Error of the Mean | 0.15380 | 2-Sided | 95 | -0.2991 | 0.3260 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.431 | LS Mean Difference | -0.1164 | Standard Error of the Mean | 0.14608 | 2-Sided | 95 | -0.4133 | 0.1804 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.020 | LS Mean Difference | -0.3269 | Standard Error of the Mean | 0.13362 | 2-Sided | 95 | -0.5985 | -0.0554 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.562 | LS Mean Difference | -0.0845 | Standard Error of the Mean | 0.14418 | 2-Sided | 95 | -0.3775 | 0.2085 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.216 | LS Mean Difference | -0.1727 | Standard Error of the Mean | 0.13695 | 2-Sided | 95 | -0.4510 | 0.1056 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.962 | LS Mean Difference | -0.0084 | Standard Error of the Mean | 0.17609 | 2-Sided | 95 | -0.3663 | 0.3495 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.852 | LS Mean Difference | -0.0357 | Standard Error of the Mean | 0.19001 | 2-Sided | 95 | -0.4218 | 0.3505 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.241 | LS Mean Difference | -0.2154 | Standard Error of the Mean | 0.18048 | 2-Sided | 95 | -0.5822 | 0.1514 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.443 | LS Mean Difference | -0.1380 | Standard Error of the Mean | 0.17766 | 2-Sided | 95 | -0.4991 | 0.2230 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.295 | LS Mean Difference | -0.2037 | Standard Error of the Mean | 0.19170 | 2-Sided | 95 | -0.5933 | 0.1859 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.743 | LS Mean Difference | -0.0602 | Standard Error of the Mean | 0.18209 | 2-Sided | 95 | -0.4303 | 0.3098 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.277 | LS Mean Difference | -0.1774 | Standard Error of the Mean | 0.16068 | 95 | -0.5040 | 0.1491 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.758 | LS Mean Difference | -0.0539 | Standard Error of the Mean | 0.17338 | 2-Sided | 95 | -0.4062 | 0.2985 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.012 | LS Mean Difference | -0.4377 | Standard Error of the Mean | 0.16468 | 2-Sided | 95 | -0.7724 | -0.1031 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.490 | LS Mean Difference | -0.1037 | Standard Error of the Mean | 0.14849 | 2-Sided | 95 | -0.4055 | 0.1981 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.534 | LS Mean Difference | -0.1007 | Standard Error of the Mean | 0.16023 | 2-Sided | 95 | -0.4263 | 0.2249 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.169 | LS Mean Difference | -0.2140 | Standard Error of the Mean | 0.15219 | 2-Sided | 95 | -0.5233 | 0.0953 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.070 | LS Mean Difference | -0.2641 | Standard Error of the Mean | 0.14118 | 2-Sided | 95 | -0.5510 | 0.0228 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.579 | LS Mean Difference | -0.0854 | Standard Error of the Mean | 0.15234 | 2-Sided | 95 | -0.3950 | 0.2242 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.100 | LS Mean Difference | -0.2446 | Standard Error of the Mean | 0.14470 | 2-Sided | 95 | -0.5387 | 0.0494 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.113 | LS Mean Difference | -0.2200 | Standard Error of the Mean | 0.13533 | 2-Sided | 95 | -0.4950 | 0.0550 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.720 | LS Mean Difference | -0.0527 | Standard Error of the Mean | 0.14603 | 2-Sided | 95 | -0.3495 | 0.2440 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.196 | LS Mean Difference | -0.1830 | Standard Error of the Mean | 0.13870 | 2-Sided | 95 | -0.4649 | 0.0989 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.313 | LS Mean Difference | -0.2051 | Standard Error of the Mean | 0.20032 | 2-Sided | 95 | -0.6122 | 0.2020 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.908 | LS Mean Difference | 0.0253 | Standard Error of the Mean | 0.21616 | 2-Sided | 95 | -0.4140 | 0.4646 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.148 | LS Mean Difference | -0.3042 | Standard Error of the Mean | 0.20531 | 2-Sided | 95 | -0.7214 | 0.1131 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.067 | LS Mean Difference | -0.3409 | Standard Error of the Mean | 0.17997 | 2-Sided | 95 | -0.7066 | 0.0249 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.739 | LS Mean Difference | -0.0652 | Standard Error of the Mean | 0.19419 | 2-Sided | 95 | -0.4599 | 0.3294 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.031 | LS Mean Difference | -0.4163 | Standard Error of the Mean | 0.18445 | 2-Sided | 95 | -0.7912 | -0.0415 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.166 | LS Mean Difference | -0.2032 | Standard Error of the Mean | 0.14369 | 2-Sided | 95 | -0.4952 | 0.0888 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.552 | LS Mean Difference | 0.0932 | Standard Error of the Mean | 0.15504 | 2-Sided | 95 | -0.2219 | 0.4083 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.271 | LS Mean Difference | -0.1648 | Standard Error of the Mean | 0.14727 | 2-Sided | 95 | -0.4641 | 0.1345 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.129 | LS Mean Difference | -0.2516 | Standard Error of the Mean | 0.16169 | 2-Sided | 95 | -0.5802 | 0.0770 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.468 | LS Mean Difference | 0.1279 | Standard Error of the Mean | 0.17447 | 2-Sided | 95 | -0.2266 | 0.4825 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.228 | LS Mean Difference | -0.2033 | Standard Error of the Mean | 0.16572 | 2-Sided | 95 | -0.5401 | 0.1334 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.141 | LS Mean Difference | -0.2000 | Standard Error of the Mean | 0.13268 | 2-Sided | 95 | -0.4696 | 0.0696 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.964 | LS Mean Difference | -0.0065 | Standard Error of the Mean | 0.14317 | 2-Sided | 95 | -0.2975 | 0.2844 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.164 | LS Mean Difference | -0.1935 | Standard Error of the Mean | 0.13599 | 2-Sided | 95 | -0.4699 | 0.0828 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.285 | LS Mean Difference | -0.1446 | Standard Error of the Mean | 0.13315 | 2-Sided | 95 | -0.4152 | 0.1260 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.903 | LS Mean Difference | -0.0176 | Standard Error of the Mean | 0.14368 | 2-Sided | 95 | -0.3096 | 0.2744 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.245 | LS Mean Difference | -0.1615 | Standard Error of the Mean | 0.13647 | 2-Sided | 95 | -0.4388 | 0.1159 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.429 | LS Mean Difference | 0.3659 | Standard Error of the Mean | 0.45708 | 2-Sided | 95 | -0.5630 | 1.2948 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.937 | LS Mean Difference | 0.0395 | Standard Error of the Mean | 0.49321 | 2-Sided | 95 | -0.9628 | 1.0419 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.101 | LS Mean Difference | 0.7902 | Standard Error of the Mean | 0.46847 | 2-Sided | 95 | -0.1618 | 1.7423 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.321 | LS Mean Difference | -0.4404 | Standard Error of the Mean | 0.43756 | 2-Sided | 95 | -1.3296 | 0.4488 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.328 | LS Mean Difference | -0.4685 | Standard Error of the Mean | 0.47214 | 2-Sided | 95 | -1.4280 | 0.4910 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.356 | LS Mean Difference | 0.4200 | Standard Error of the Mean | 0.44846 | 2-Sided | 95 | -0.4914 | 1.3314 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32. Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.188 | LS Mean Difference | -0.2254 | Standard Error of the Mean | 0.16790 | 2-Sided | 95 | -0.5666 | 0.1158 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.899 | LS Mean Difference | -0.0232 | Standard Error of the Mean | 0.18117 | 2-Sided | 95 | -0.3914 | 0.3449 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.150 | LS Mean Difference | -0.2534 | Standard Error of the Mean | 0.17208 | 2-Sided | 95 | -0.6032 | 0.0963 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA3: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.148 | LS Mean Difference | -0.2821 | Standard Error of the Mean | 0.19038 | 2-Sided | 95 | -0.6690 | 0.1048 | Difference between least square means of TAK-063 3 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.817 | LS Mean Difference | -0.0480 | Standard Error of the Mean | 0.20543 | 2-Sided | 95 | -0.4655 | 0.3695 | Difference between least square means of TAK-063 10 mg and Placebo. | Superiority or Other (legacy) |
| Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest. | ANOVA | 0.091 | LS Mean Difference | -0.3395 | Standard Error of the Mean | 0.19513 | 2-Sided | 95 | -0.7361 | 0.0570 | Difference between least square means of TAK-063 30 mg and Placebo. | Superiority or Other (legacy) |
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| Participants |
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| TAK-063 300 mg |
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3. |
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TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
| OG004 | TAK-063 300 mg | TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3. |
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TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
| OG004 | TAK-063 300 mg | TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3. |
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| OG004 | TAK-063 300 mg | TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3. |
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