A Phase II, 6-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group trial with a quetiapine arm to evaluate the efficacy, tolerability and safety of oral BI 1358894 in patients with Major Depressive Disorder with inadequate response to antidepressants.

Boehringer Ingelheim0 个研究点目标入组 431 人开始时间: 2020年8月12日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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).

•-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.

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