Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo

Phase 4 Completed 110 enrolled Pfizer

RandomizedParallel-groupTriple-blindTreatment

Summary

Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.

Timeline

Start: 2008-09
Primary completion: 2009-07
Completion: 2009-08

Outcome

Missed primary endpoint

paper There were no significant differences between groups for the MADRS (treatment difference vs. placebo = .03, 95% confidence interval [CI] -.68-.73; NS) PMID 21295286 ↗

Publications

Garza D, Murphy M, Tseng LJ, Riordan HJ, Chatterjee A. A double-blind randomized placebo-controlled pilot study of neuropsychiatric adverse events in abstinent smokers treated with varenicline or placebo. Biol Psychiatry. 2011 Jun 1;69(11):1075-82. doi: 10.1016/j.biopsych.2010.12.005. Epub 2011 Feb 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Varenicline	Small molecule	1 mg	Oral

Indications

No indication recorded.