Varenicline in Bipolar Depressed Patients

NCT00813800 | Completed Results

• 1 other identifier: 08-003471
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Smoking; Bipolar Disorder; Depression

Keywords

Smoking; Bipolar Disorder; Depression

Outcome Measures

Primary Outcomes (1)

• Carbon Monoxide Breath Level at 12 Weeks

  Measured by expired breath in parts per million (ppm)

  12 weeks

Secondary Outcomes (2)

• Montgomery-Asberg Depression Rating Scale (MADRS) at 12 Weeks

  12 weeks

• Young Mania Rating Scale (YMRS) at 12 Weeks

  12 weeks

Study Arms (1)

Varenicline

EXPERIMENTAL

Open-label; subjects will receive a behavioral intervention in addition to Varenicline.

Drug: Varenicline

Interventions

Varenicline DRUG

Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.

Also known as: Chantix

Varenicline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 -65 years
• Meet DSM-IV criteria for bipolar disorder type I or II and nicotine dependence
• DSM-IV confirmed current major depressive episode OR current depressive symptoms defined as MADRS \> 4 \& \<20
• Smoke at least 10 cigarettes per day
• Fagerström Test of Nicotine Dependence (FTND) score of 5 or higher
• Agree to identify collateral individuals for contact purposes to facilitate follow-up appointments
• Currently on mood stabilization treatment. A minimum daily therapeutic dosage of at least one mood stabilizer, and on the same dose for at least 2 weeks:
• Lithium (0.6-1.2 mEq/L or 900 mg), Valproate (50-125 mg/mL or 1000 mg), Carbamazepine (4-12 mg/mL or 800 mg), Oxcarbazepine 1200 mg, Lamotrigine 100 mg, Olanzapine 10mg, Risperidone 2mg, Quetiapine 300mg, Ziprasidone 40mg, Aripiprazole 7.5 mg
• Topiramate is an acceptable mood stabilization treatment. There is an evidence base (Delbello et al. 2005) highlighting efficacy of topiramate monotherapy for acute mania in children and adolescents with bipolar disorder type 1.
• \[Mood stabilizers are a standard American Psychiatric Association (APA) treatment guidelines for Bipolar I disorder (history of mania). While the guidelines for Bipolar II disorder are unclear (history of hypomania), we feel mood stabilization provides standardization of treatment and maximizes safety (ie: preventing switch from depression to mania or hypomania).\]

You may not qualify if:

• DSM-IV dependence for a substance other than nicotine or caffeine within past 3 months.
• DSM-IV criteria of schizophrenia or other non-affective psychotic disorder
• Psychotic symptoms within the past month
• Active suicidality as measured by screening questions from the Columbia-Suicide Severity Rating Scale (C-SSRS
• History of medically serious suicide attempt as reviewed by doctor.
• Current use (past 30 days) of other smoking cessation treatments
• Pregnant or nursing women, or women who refuse to use adequate birth control
• Serious, active or unstable medical condition
• Individuals, in the investigators opinion, unable to comply with study procedures
• Inability to provide written informed consent in English
• Allergic reaction to varenicline
• Individuals who are on dialysis or have a history of kidney disease (varenicline is excreted 96% unchanged through the kidneys) or Creatine supplementation or current anticipated daily NSAID use
• Presence of a personality disorder, that upon review of the medical record, appears to be the primary reason for psychiatric care.

Sponsors & Collaborators

• Mark Frye: lead
• Pfizer: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Smoking; Bipolar Disorder; Depression

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

Small sample size; limitations finding participants with stable state within their bipolar disorder.

Results Point of Contact

• Title: Mark Frye, MD
• Organization: Mayo Clinic

mfrye@mayo.edu

507-255-9391

Study Officials

• Mark A. Frye, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Professor of Psychiatry, College of Medicine

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 23, 2008
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: January 30, 2012
• Results First Posted: January 30, 2012

Record last verified: 2011-12

Locations

US (1)