At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 298 enrolled
Drug / intervention
Pimavanserin +1 moredrug
Likely dose
Pimavanserin 34 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Pimavanserin and Placebo for Adjunctive Treatment of Major Depressive Disorder. Completed, enrolled 298 participants across 85 sites in 9 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFinland, Poland, Russia, Serbia, Slovakia, South Africa, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartApr 2019
First PostedMay 2019
Primary CompletionApr 2020
Study CompletionMay 2020
TodayJul 2026
First PostedMay 30, 2019
Enrollment StartApr 25, 2019
Primary CompletionApr 30, 2020
Study CompletionMay 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.1 years ago
Interventions
Pimavanserindrug
Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily
Placebodrug
Placebo (2×placebo tablets \[size- and color-matched to pimavanserin\]) administered orally as a single dose once daily