A Phase 2 Trial of OPC-64005 for Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Registration Number
- JPRN-jRCT2080225024
- Lead Sponsor
- Otsuka Pharmaceutical Co., LTD.
- Brief Summary
The primary endpoint of mean change from baseline in MADRS total score at Week 6 of the double-blind treatment period was numerically greater in the 20-mg group than in the placebo group, but statistical superiority of the 20-mg group to the placebo group was not demonstrated.No major safety concerns were observed in either the 20-mg or 10-mg group and OPC-64005 was well tolerated.
- 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 and more than 4 weeks to 1 and less than 1 year
- Patients with a total score of 18 and more than 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
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Montgomery-Asberg Depression Rating Scale
- Secondary Outcome Measures
Name Time Method efficacy<br>MADRS,CGI-I,CGI-S,HAM-D,MADRS-S,Apathy scale