drugset / Trial / NCT00813800

Varenicline in Bipolar Depressed Patients

NCT00813800

Completed 11 enrolled Mark Frye Pfizer · collab
NaSingle-groupOpen-labelTreatment

Summary

Patients with bipolar disorder have one of the highest rates of nicotine dependence and one of the lowest quit rates. Varenicline has been shown in previous trials to be effective for smoking cessation, but has not been studied in subjects with bipolar disorder. This 12-week open label trial will be conducted to assess the feasibility, acceptability, and safety of varenicline in bipolar depressed smokers, given in addition to the subject's primary treatment for bipolar disorder. The primary study hypothesis was that the abstinence rate for bipolar depressed patients will be 50%.

Timeline

Start
2009-01
Primary completion
2011-01
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Varenicline Small molecule 1 mg Oral