Phase 2
N=273
A Phase 2 Trial of OPC-64005 for Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04244253 ↗Enrolled (actual)
273
Serious AEs
1.1%
Results posted
Sep 2024
Primary outcome: Primary: Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period — -1.9; -1.6; -2.1; -3.9 Units on a scale — p=0.288
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OPC-64005 20 mg , Once-daily (Drug); OPC-64005 10 mg , Once-daily (Drug); Placebo, Once-daily (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period |
-1.9; -1.6; -2.1; -3.9; -3.4; -3.6 | 0.288 |
| SECONDARY MADRS Response Rate |
0.0; 0.8; 0.8; 3.2; 5.0; 3.3 | 0.329 |
| SECONDARY MADRS Remission Rate |
16.1; 14.9; 13.3 | 0.731 |
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
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT04244253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.