A study to test the effect of different doses of BI 1358894 and quetiapine in people with depression.
- Conditions
- Major Depressive Disorder
- Registration Number
- JPRN-jRCT2080225310
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 431
Established diagnosis of Major Depressive Disorder (MDD), single episode or recurrent, as confirmed at the time of screening by the Structured Clinical Interview for DSM-5 (SCID-5), with a duration of current depressive episode >= 8 weeks and =< 24 months at the time of screening visit.
-Montgomery-Asberg Depression Rating Scale (MADRS) total score >= 24 at screening, as confirmed by a trained site based rater AND interactive, computer administered MADRS. The difference in the rater and computer administered MADRS must not exceed more than 7 points. In addition, trial participants must have a score of >= 3 on the Reported Sadness Item on both MADRS scales (computer-administered and rater-administered MADRS).
-A documented ongoing monotherapy treatment of >= 4 weeks at the screening visit, with a protocol specified SSRI or SNRI at
adequate dose (at least minimum effective dose as per prescribing information and as confirmed per detectable drug levels in the
screening blood sampling).
etc.
-Per DSM-5, has ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder or MDD with psychotic features as assessed by the SCID-5 at the time of screening.
-Diagnosis of any other mental disorder (in addition to those as described in EX#1) that was primary focus of treatment within 6
months prior to screening or at baseline (as per clinical discretion of the investigator).
-Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder as per DSM-5 criteria, at the time of screening visit. Any other personality disorder at screening visit that significantly affects current psychiatric status and likely to impact trial participation, as per the judgement of investigator.
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>exploratory<br>Change from baseline in MADRS total score at Week 6
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>exploratory<br>-Response defined as >= 50% MADRS reduction from baseline at Weeks 6<br>-Change from baseline in STAI State and Trait version scores at Week 6<br>-Change from baseline in Clinical Global Impression Severity Scale (CGI-S) score at Week 6<br>-Change from baseline in SMDDS total score at Week 6