NCT03968159

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Adjunctive Treatment of Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Pimavanserin	Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily
DRUG	Placebo	Placebo (2×placebo tablets \[size- and color-matched to pimavanserin\]) administered orally as a single dose once daily

Timeline

• Start date: 2019-04-25
• Primary completion: 2020-04-30
• Completion: 2020-05-29
• First posted: 2019-05-30
• Last updated: 2021-11-17
• Results posted: 2021-11-17

Locations

85 sites across 9 countries: United States, Finland, Poland, Russia, Serbia, Slovakia, South Africa, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study