Major Depressive Disorder
Conditions
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 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.
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory Change from baseline in MADRS total score at Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory -Response defined as >= 50% MADRS reduction from baseline at Weeks 6 -Change from baseline in STAI State and Trait version scores at Week 6 -Change from baseline in Clinical Global Impression Severity Scale (CGI-S) score at Week 6 -Change from baseline in SMDDS total score at Week 6 | — |
Countries
Europe, Japan, North America
Outcome results
None listed