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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

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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Apr 2024

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At a glance

  • Drugs BI 1358894 (Primary) ; Quetiapine
  • Indications Major depressive disorder
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Boehringer Ingelheim; Boehringer Ingelheim Pharma KG

    • Most Recent Events

    • 14 Feb 2024 This trial has been completed in Poland and Hungary according to European Clinical Trials Database.
    • 05 Feb 2024 Status changed from active, no longer recruiting to completed.
    • 09 Jan 2024 Planned primary completion date changed from 4 Jan 2024 to 15 Jan 2024.

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