Safety and efficacy of adjunctive Pimavanserin for depression
Research type
Research Study
Full title
A 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
IRAS ID
264771
Contact name
Aliya Asher
Contact email
Sponsor organisation
ACADIA Pharmaceuticals Inc
Eudract number
2018-003251-37
Duration of Study in the UK
1 years, 7 months, 1 days
Research summary
The study will be conducted as a multicentre randomised, double-blind, placebo-controlled, parallel-group study in subjects experiencing major depressive disorder with inadequate response to a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Approximately 560 adult subjects will be screened and 280 randomised, allowing for a 50% screen failure rate. Randomised subjects will be spilt into two groups, with half receiving the study drug, pimavanserin and the other half receiving placebo (inactive pill).
The study will have three periods:
• Screening period (3-21 days)
• Double-blind treatment period (6 weeks)
• Safety follow-up period (at least 30 days.The duration of participation for individual study subjects will be up to 14 weeks.
Approximately 40 sites will participate in this study.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0151
Date of REC Opinion
11 Jun 2019
REC opinion
Further Information Favourable Opinion