Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-205116 | Other Identifier | JapicCTI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the trial is to compare the efficacy of OPC-64005 at 20 mg vs placebo and to assess the safety and pharmacokinetics of OPC-64005 at 10 and 20 mg in patients with major depressive disorder (MDD).The primary endpoint is the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 of the double-blind treatment period in the OPC-64005 20-mg group compared with the placebo group
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-64005 20 mg | Experimental |
| |
| OPC-64005 10 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-64005 20 mg , Once-daily | Drug | Active, High Dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period | The MADRS was a clinician-rated scale which evaluated the level of depression. The MADRS consists of following 10 depressive symptoms on 7 scales of 0 to 6, with higher scores indicating worse condition. 1. Apparent sadness, 2. Reported sadness, 3. Inner tension, 4. Reduced sleep, 5. Reduced appetite, 6. Concentration difficulties, 7. Lassitude, 8. Inability to feel, 9. Pessimistic thoughts, and 10. Suicidal thoughts Summed subscales were combined to compute a total score. Total score ranges form 0 to 60, with higher scores indicating worse condition. | Baseline, Week 1, 2, 3, 4, 5, and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| MADRS Response Rate | The MADRS response rate is the percentage of subjects with ≥50% reduction from baseline in MADRS total score at Week 6 of the double-blind treatment period. | Baseline, Week 1, 2, 3, 4, 5, and 6 |
| MADRS Remission Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Takehisa Matsumaru | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Jisenkai Himorogi Psychiatric Institute | Tokyo | Japan |
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
Not provided
Adult subjects with Major Depressive Disorder defined by criteria of the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5).
This trial was conducted in 273 subjects from 69 trial sites in Japan.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | OPC-64005 10-mg | One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 6 weeks |
| FG001 | OPC-64005 20-mg | One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 1 week, followed by two OPC-64005 10-mg tablets for 5 weeks |
| FG002 | Placebo | Two placebo tablets administered orally once daily for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set includes all subjects who were administered at least 1 dose of double-blind IMP.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OPC-64005 10-mg | One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 6 weeks |
| BG001 | OPC-64005 20-mg | One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 1 week, followed by two OPC-64005 10-mg tablets for 5 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period | The MADRS was a clinician-rated scale which evaluated the level of depression. The MADRS consists of following 10 depressive symptoms on 7 scales of 0 to 6, with higher scores indicating worse condition. 1. Apparent sadness, 2. Reported sadness, 3. Inner tension, 4. Reduced sleep, 5. Reduced appetite, 6. Concentration difficulties, 7. Lassitude, 8. Inability to feel, 9. Pessimistic thoughts, and 10. Suicidal thoughts Summed subscales were combined to compute a total score. Total score ranges form 0 to 60, with higher scores indicating worse condition. | The full analysis set (FAS) includes all subjects who were administered at least 1 dose of double-blind IMP and have MADRS total scores at baseline and at least one time point after the start of double-blind treatment. FAS excluded one subject in the placebo group for whom no MADRS total score was obtained after start of double-blind treatment. | Posted | Mean | Standard Error | Units on a scale | Baseline, Week 1, 2, 3, 4, 5, and 6 |
|
Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration.
An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this 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 | OPC-64005 10-mg | One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 6 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA/J Ver.24.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA/J Ver.24.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 31, 2020 | Feb 2, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 4, 2022 | Feb 2, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OPC-64005 10 mg , Once-daily |
| Drug |
Active, Low Dose |
|
| Placebo, Once-daily | Drug | Placebo |
|
MADRS remission rate is the percentage of subjects with MADRS total score ≤ 10 and ≥ 50% reduction from baseline in MADRS total score at Week 6 of the double-blind treatment period.
| Week6 |
| Withdrawal by Subject |
|
| Non-Compliance With Study Drug |
|
| BG002 | Placebo | Two placebo tablets administered orally once daily for 6 weeks |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | OPC-64005 10-mg | One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 6 weeks |
| OG001 | OPC-64005 20-mg | One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 1 week, followed by two OPC-64005 10-mg tablets for 5 weeks |
| OG002 | Placebo | Two placebo tablets administered orally once daily for 6 weeks |
|
|
|
| Secondary | MADRS Response Rate | The MADRS response rate is the percentage of subjects with ≥50% reduction from baseline in MADRS total score at Week 6 of the double-blind treatment period. | The full analysis set (FAS) included all subjects who were administered at least 1 dose of double-blind IMP and had MADRS total scores at baseline and at least one time point after the start of double-blind treatment. | Posted | Number | percentage of participants | Baseline, Week 1, 2, 3, 4, 5, and 6 |
|
|
|
|
| Secondary | MADRS Remission Rate | MADRS remission rate is the percentage of subjects with MADRS total score ≤ 10 and ≥ 50% reduction from baseline in MADRS total score at Week 6 of the double-blind treatment period. | The full analysis set (FAS) included all subjects who were administered at least 1 dose of double-blind IMP and had MADRS total scores at baseline and at least one time point after the start of double-blind treatment. | Posted | Number | percentage of participants | Week6 |
|
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 7 |
| 31 |
| EG001 | OPC-64005 20-mg | One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 1 week, followed by two OPC-64005 10-mg tablets for 5 weeks | 0 | 121 | 2 | 121 | 19 | 121 |
| EG002 | Placebo | Two placebo tablets administered orally once daily for 6 weeks | 0 | 121 | 1 | 121 | 19 | 121 |
| Major depression | Psychiatric disorders | MedDRA/J Ver.24.1 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA/J Ver.24.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA/J Ver.24.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/J Ver.24.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA/J Ver.24.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/J Ver.24.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 3Week |
|
| 4Week |
|
| 5Week |
|
| 6Week |
|