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Adjunctive Pimavanserin in Patients with Major Depressive Disorder: Combined Results from Two Randomized, Double-Blind, Placebo-Controlled Phase 3 Studies.
Dirks, Bryan; Fava, Maurizio; Atkinson, Sarah D; Joyce, Mark; Thase, Michael E; Howell, Becky; Lin, Tim; Stankovic, Serge.
  • Dirks B; Bryan Dirks, Acadia Pharmaceuticals Inc, San Diego, CA, USA.
  • Fava M; Maurizio Fava, Department of Psychiatry, Massachusetts General Hospital, and Harvard Medical School, Boston, MA, USA.
  • Atkinson SD; Sarah D. Atkinson, Evolution Research Group, Rochester, NY, USA.
  • Joyce M; Mark Joyce, CNS Healthcare, Jacksonville, FL, USA.
  • Thase ME; Michael E. Thase, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, USA.
  • Howell B; Becky Howell, Acadia Pharmaceuticals Inc, Princeton, NJ, USA.
  • Lin T; Tim Lin, Acadia Pharmaceuticals Inc, San Diego, CA, USA.
  • Stankovic S; Serge Stankovic, Acadia Pharmaceuticals Inc, San Diego, CA, USA.
Psychopharmacol Bull ; 52(4): 8-30, 2022 Oct 27.
Article in English | MEDLINE | ID: covidwho-2101824
ABSTRACT

Objective:

In a phase 2 study, pimavanserin demonstrated efficacy as adjunctive treatment for major depressive disorder (MDD). Subsequently, two phase 3 studies (NCT03968159 in the US; NCT03999918 in Europe) were initiated to examine the efficacy and safety of adjunctive pimavanserin in subjects with MDD and inadequate response to antidepressant treatment. Studies were combined with a prespecified statistical analysis plan owing to recruitment challenges related to the COVID-19 pandemic. Experimental

design:

The randomized, double-blind studies enrolled 298 patients with MDD and inadequate response to current antidepressants. Patients were randomly assigned 11 to pimavanserin or placebo added to current antidepressant for 6 weeks. Primary endpoint was change from baseline to week 5 in the Hamilton Rating Scale for Depression, 17-item version (HAM-D-17). Principal observations There was no effect of pimavanserin in change from baseline to week 5 in the HAM-D-17 (pimavanserin [n = 138] least-squares mean [LSM] [standard error {SE}], -9.0 [0.58]; placebo [n = 135] -8.1 [0.58]; mixed-effects model for repeated measures LSM [SE] difference, -0.9 [0.82], P = 0.2956). Nominal improvement with pimavanserin was observed on 2 secondary endpoints Clinical Global Impressions-Severity scale, Karolinska Sleepiness Scale. Treatment-emergent adverse events occurred in 58.1% of pimavanserin-treated and 54.7% of placebo-treated patients.

Conclusions:

Adjunctive pimavanserin did not significantly improve depressive symptoms, although pimavanserin was well tolerated.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Depressive Disorder, Major / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Psychopharmacol Bull Year: 2022 Document Type: Article Affiliation country: United States

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Depressive Disorder, Major / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Psychopharmacol Bull Year: 2022 Document Type: Article Affiliation country: United States