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| ID | Type | Description | Link |
|---|---|---|---|
| KETIVTRD2002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to explore the optimal dose frequency of ketamine in patients with treatment-resistant depression (TRD).
This is a double-blind (patients and study personnel do not know the identity of the administered treatments), randomized (the drug is assigned by chance), placebo-controlled (placebo is a substance that appears identical to the treatment and has no active ingredients), parallel arm study (each group of patients will be treated at the same time). The study will consist of a screening phase of up to 4 weeks, a 4-week double-blind treatment phase (Day 1 to Day 29), and a 3-week post treatment (follow up) phase. In the double-blind phase, patients will receive over 4 weeks either intravenous (IV) infusions of placebo (2 or 3 times weekly) or IV infusions of ketamine (2 or 3 times weekly). The total study duration for each patient will be a maximum of 13 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo 3 times/week | Placebo Comparator |
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| Ketamine 3 times/week | Experimental |
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| Ketamine 2 times/week | Experimental |
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| Placebo 2 times/week | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Form= intravenous infusion, route= intravenous (IV) use. IV infusions of placebo 2 times weekly or IV infusions of placebo 3 times weekly. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15 | The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. | Baseline (Day 1) and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 29 | The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31270774 | Derived | Lewis S, Romano C, De Bruecker G, Murrough JW, Shelton R, Singh JB, Jamieson C. Analysis of Clinical Trial Exit Interview Data in Patients with Treatment-Resistant Depression. Patient. 2019 Oct;12(5):527-537. doi: 10.1007/s40271-019-00369-8. | |
| 28086004 | Derived | Johnson KM, Devine JM, Ho KF, Howard KA, Saretsky TL, Jamieson CA. Evidence to Support Montgomery-Asberg Depression Rating Scale Administration Every 24 Hours to Assess Rapid Onset of Treatment Response. J Clin Psychiatry. 2016 Dec;77(12):1681-1686. doi: 10.4088/JCP.15m10253. |
| Label | URL |
|---|---|
| A Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose Frequency Study of Ketamine in Subjects With Treatment-resistant Depression | View source |
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A total of 165 participants were screened and 68 participants were randomized into the study. Of these 68 participants randomized, 67 participants received at least 1 dose of the study agent (Intent-To-Treat analysis set).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo: 2 Times Per Week | Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks. |
| FG001 | Ketamine: 2 Times Per Week | Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ketamine | Drug | Type= exact number, unit= mg/kg, number= 0.5, form= intravenous infusion, route= intravenous (IV) use. IV infusions of ketamine 0.50 mg/kg, 2 times weekly or IV infusions of ketamine 0.50 mg/kg, 3 times weekly. |
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| Baseline (Day 1) and Day 29 |
| Number of Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Participants with a reduction in the MADRS total score of greater than or equal to (>=) 50 percent from baseline were defined as responders. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. | Day 15 and Day 29 |
| Number of Remitters Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Participants who had a MADRS total score of less than or equal to (<=) 10 were considered remitters. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. | Day 15 and Day 29 |
| Number of Sustained Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Sustained response on Day 15 was defined as achieving an onset of antidepressant response within the first week that is maintained to the end of study Day 15. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. | Day 15 |
| Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Endpoint (Day 29) | The CGI-S was used to rate the severity of the participants illness at the time of assessment, relative to the clinician's past experience with participants who had the same diagnosis and improvement with treatment. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to: 0= not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. | Baseline (Day 1) and Endpoint (Day 29) |
| Clinical Global Impression of Improvement (CGI-I) Score at Endpoint of Double Blind Phase | The CGI-I is a 7-point scale that was used to assess how much the participants illness was improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 0= not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | Endpoint (Day 29) |
| Change in Patient Global Impression-Severity (PGI-S) Score From Baseline to Endpoint (Day 29) | The PGI-S is an 11-point (0 to 10) scale that required the participant to rate the severity of their illness at the time of assessment, relative to the participants past experience. Considering their total experience, the participant was to assess the severity of their depression illness at the time of rating as none, mild, moderate or severe. The scale is rated as, 0=very well and 10=very poor. | Baseline (Day 1) and Endpoint (Day 29) |
| Patient Global Impression-Change (PGI-C) Score at Endpoint of Double Blind Phase | The PGI-C is a 7-point scale that required the subject to assess how much their illness had improved or worsened relative to a baseline state at the beginning of the intervention. The response options were: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse. The scale is rated as, 1=very much improved and 7=very much worse. | Endpoint (Day 29) |
| Maximum Observed Plasma Concentration (Cmax) of Ketamine | The Cmax is the maximum observed plasma concentration of drug. | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ketamine | The Tmax is defined as actual sampling time to reach maximum observed drug concentration. | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC[0-last]) | The AUC(0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time. | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) | The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
| Total Systemic Clearance (CL) of Ketamine | The CL is a quantitative measure of the rate at which a drug substance is removed from the body. | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
| Volume of Distribution at Steady-State (Vss) of Ketamine | The Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of ketamine at steady state. | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
| Elimination Half-Life (t1/2) | The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
| Little Rock |
| Arkansas |
| United States |
| Centennial | Colorado | United States |
| Hartford | Connecticut | United States |
| New Haven | Connecticut | United States |
| Atlanta | Georgia | United States |
| Rockville | Maryland | United States |
| Marlton | New Jersey | United States |
| New York | New York | United States |
| Allentown | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Dallas | Texas | United States |
| Salt Lake City | Utah | United States |
| FG002 | Placebo: 3 Times Per Week | Participants received IV infusion of placebo 3 times weekly for 4 weeks. |
| FG003 | Ketamine: 3 Times Per Week | Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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The Intent-To-Treat (ITT) analysis set is defined as participants who were randomized and received at least 1 dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo: 2 Times Per Week | Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks. |
| BG001 | Ketamine: 2 Times Per Week | Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks. |
| BG002 | Placebo: 3 Times Per Week | Participants received IV infusion of placebo 3 times weekly for 4 weeks. |
| BG003 | Ketamine: 3 Times Per Week | Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks. |
| BG004 | 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: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15 | The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Day 1) and Day 15 |
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| Secondary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 29 | The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Day 1) and Day 29 |
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| Secondary | Number of Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Participants with a reduction in the MADRS total score of greater than or equal to (>=) 50 percent from baseline were defined as responders. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively | Posted | Number | Participants | Day 15 and Day 29 |
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| Secondary | Number of Remitters Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Participants who had a MADRS total score of less than or equal to (<=) 10 were considered remitters. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively | Posted | Number | Participants | Day 15 and Day 29 |
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| Secondary | Number of Sustained Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Sustained response on Day 15 was defined as achieving an onset of antidepressant response within the first week that is maintained to the end of study Day 15. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | Participants | Day 15 |
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| Secondary | Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Endpoint (Day 29) | The CGI-S was used to rate the severity of the participants illness at the time of assessment, relative to the clinician's past experience with participants who had the same diagnosis and improvement with treatment. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to: 0= not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively | Posted | Median | Full Range | Units on a scale | Baseline (Day 1) and Endpoint (Day 29) |
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| Secondary | Clinical Global Impression of Improvement (CGI-I) Score at Endpoint of Double Blind Phase | The CGI-I is a 7-point scale that was used to assess how much the participants illness was improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 0= not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Median | Full Range | Units on a scale | Endpoint (Day 29) |
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| Secondary | Change in Patient Global Impression-Severity (PGI-S) Score From Baseline to Endpoint (Day 29) | The PGI-S is an 11-point (0 to 10) scale that required the participant to rate the severity of their illness at the time of assessment, relative to the participants past experience. Considering their total experience, the participant was to assess the severity of their depression illness at the time of rating as none, mild, moderate or severe. The scale is rated as, 0=very well and 10=very poor. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively | Posted | Median | Full Range | Units on a scale | Baseline (Day 1) and Endpoint (Day 29) |
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| Secondary | Patient Global Impression-Change (PGI-C) Score at Endpoint of Double Blind Phase | The PGI-C is a 7-point scale that required the subject to assess how much their illness had improved or worsened relative to a baseline state at the beginning of the intervention. The response options were: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse. The scale is rated as, 1=very much improved and 7=very much worse. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Median | Full Range | Units on a scale | Endpoint (Day 29) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Ketamine | The Cmax is the maximum observed plasma concentration of drug. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/ml) | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ketamine | The Tmax is defined as actual sampling time to reach maximum observed drug concentration. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively | Posted | Median | Full Range | Hour | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC[0-last]) | The AUC(0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively | Posted | Mean | Standard Deviation | hour*nanogram per milliliter | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) | The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively | Posted | Mean | Standard Deviation | hour*nanogram per milliliter | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
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| Secondary | Total Systemic Clearance (CL) of Ketamine | The CL is a quantitative measure of the rate at which a drug substance is removed from the body. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively | Posted | Mean | Standard Deviation | liter per hour | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
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| Secondary | Volume of Distribution at Steady-State (Vss) of Ketamine | The Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of ketamine at steady state. | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively | Posted | Mean | Standard Deviation | liter | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
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| Secondary | Elimination Half-Life (t1/2) | The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively | Posted | Mean | Standard Deviation | hour | Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15 |
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Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
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: 2 Times Per Week | Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks. | 0 | 16 | 9 | 16 | ||
| EG001 | Ketamine: 2 Times Per Week | Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks. | 2 | 18 | 15 | 18 | ||
| EG002 | Placebo: 3 Times Per Week | Participants received IV infusion of placebo 3 times weekly for 4 weeks. | 0 | 16 | 8 | 16 | ||
| EG003 | Ketamine: 3 Times Per Week | Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks. | 0 | 17 | 13 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Suicide Attempt | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Flutter | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Ventricular Extrasystoles | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hyperacusis | Ear and labyrinth disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Altered Visual Depth Perception | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypoaesthesia Oral | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Paraesthesia Oral | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Feeling Abnormal | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Feeling Cold | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Infusion Site Pain | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Injection Site Extravasation | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Groin Abscess | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Animal Bite | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Blood Potassium Decreased | Investigations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Drug Screen Positive | Investigations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Electrocardiogram St-T Change | Investigations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Fluid Retention | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Cognitive Disorder | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Poor Quality Sleep | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dissociation | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dissociative Disorder | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Euphoric Mood | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hallucination, Tactile | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hallucination, Visual | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Micturition Urgency | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Research | Janssen Research & Development, LLC | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Change at Day 15 (n=13,16,16,13) |
|
| < 0.001 |
| Difference of Least Square Means |
| -16.4 |
| 2-Sided |
| 70 |
| -18.96 |
| -13.84 |
| Superiority or Other (legacy) |
| OG003 | Ketamine: 3 Times Per Week | Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks. |
|
|
Participants received IV infusion of placebo 3 times weekly for 4 weeks. |
| OG003 | Ketamine: 3 Times Per Week | Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks. |
|
|
Participants received IV infusion of placebo 3 times weekly for 4 weeks. |
| OG003 | Ketamine: 3 Times Per Week | Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks. |
|
|
Participants received IV infusion of placebo 3 times weekly for 4 weeks. |
| OG003 | Ketamine: 3 Times Per Week | Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks. |
|
|
| Placebo: 3 Times Per Week |
Participants received IV infusion of placebo 3 times weekly for 4 weeks. |
| OG003 | Ketamine: 3 Times Per Week | Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks. |
|
|
| OG003 | Ketamine: 3 Times Per Week | Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks. |
|
|
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
| OG003 | Ketamine: 3 Times Per Week | Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks. |
|
|
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
| OG003 | Ketamine: 3 Times Per Week | Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks. |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|