A Phase 2 Trial of OPC-64005 for Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: OPC-64005 20 mg , Once-dailyDrug: OPC-64005 10 mg , Once-dailyDrug: Placebo, Once-daily
- Registration Number
- NCT04244253
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 273
- Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode" with the current episode persisting for ≥4 weeks to ≤1 year
- Patients with a total score of ≥18 on the 17-item Hamilton Rating Scale for Depression (HAM-D)
- Patients with a diagnosis of any of the following diseases according to DSM-5 Neurocognitive disorders, history or complication of schizophrenia spectrum or other psychotic disorder, history or complication of bipolar and related disorders, feeding and eating disorders, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, personality disorders, neurodevelopmental disorders, substance-related and addictive disorders (within 180 days prior to informed consent)
- Patients exhibiting mood-incongruent psychotic features in the current major depressive episode
- Patients who, in the opinion of the investigator or subinvestigator, are judged to have treatment-resistant depression, ie, a certain degree of therapeutic effect is not obtained by administration of 2 or more antidepressants having different mechanisms of action at sufficient doses for at least 6 weeks for the current major depressive episode
- Patients receiving augmentation treatment, such as antipsychotics, for the current major depressive episode (excluding the use of sulpiride for depression/depressive state or gastric/duodenal ulcer)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OPC-64005 20 mg OPC-64005 20 mg , Once-daily - OPC-64005 10 mg OPC-64005 10 mg , Once-daily - Placebo Placebo, Once-daily -
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period Baseline, Week 1, 2, 3, 4, 5, and 6 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.
- Secondary Outcome Measures
Name Time Method MADRS Response Rate Baseline, Week 1, 2, 3, 4, 5, and 6 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.
MADRS Remission Rate Week6 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.
Trial Locations
- Locations (1)
Medical Corporation Jisenkai Himorogi Psychiatric Institute
🇯🇵Tokyo, Japan