Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

Adjunctive Treatment of Major Depressive Disorder Clinical Trial

Official title: Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment (ACP-103-054/059)

Status Completed

Clinical Trial Summary

To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy

Clinical Trial Description

Two separate studies, idential in design, were planned and initiated under 2 protocol IDs and NCTs, i.e. study ACP-103-54 (NCT03999918) and ACP-103-059 (NCT03968159). In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. At that point in time, about half of the planned patients had been randomized. The Sponsor decided to combine the 2 identically designed trials, with a prespecified combined statistical analysis plan. As a result, both trials were closed and proceeded with database lock and statistical analysis of the combined data. No further patients were enrolled. This entry now includes the combined data of studies ACP-103-054 and ACP-103-059. ;

Related Conditions & MeSH terms

• Adjunctive Treatment of Major Depressive Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major

• NCT number: NCT03968159
• Study type: Interventional
• Source: ACADIA Pharmaceuticals Inc.
• Status: Completed
• Phase: Phase 3
• Start date: April 25, 2019
• Completion date: May 29, 2020