A Phase 4, Randomized, Double Blind, Active And Placebo Controlled Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1MG BID And Bupropion Hydrochloride 150MG BID For Smoking Cessation In Subjects With And Without A History of Psychiatric Disorders

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

At least 1 severe AE of anxiety depression, feeling abnormal, or hostility and/or moderate or severe AE of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation/behavior/completed

Outcome Time Frame:

Week 12

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A3051123

NCT ID:

NCT01456936

Start Date:

November 2011

Completion Date:

October 2016

Related Keywords:

• Smoking Cessation
• smoking cessation
• psychiatric disease
• Mental Disorders
• Smoking