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Varenicline in Bipolar Depressed Patients
This study is not yet open for participant recruitment.
Verified by Mayo Clinic, December 2008
Sponsored by: Mayo Clinic
Information provided by: Mayo Clinic Identifier: NCT00813800

Aim 1. To assess the feasibility and acceptability of varenicline among bipolar depressed smokers as determined by our recruitment and retention rates.

Hypothesis 1. The abstinence rate for bipolar depressed patients will be 50%. The retention rate for this study will be similar to the Gonzales 2006 study (approximately 75)%.

Aim 2. To estimate the 7-day point prevalence abstinence rate at week 12, with open-label varenicline and behavioral intervention among patients with bipolar depression (N=15 with major depression, N=15 with subsyndromal or depressive symptoms). The investigators primary outcome measure is 7-day point prevalence abstinence rate defined by self-report at week 12 confirmed by expired carbon monoxide levels of 10 ppm or less.

Hypothesis 2:At final visit, approximately 50% of study completers will meet the primary outcome measure. At study entry, bipolar patients with a major depressive episode, in comparison to subjects with depressive symptoms (i.e. not syndromal episode, less severe) , will have lower abstinence rates.At final visit, bipolar depressed patients who have achieved remission, defined as a Montgomery Asberg Depression Rating Scale (MADRS) <8, will have a higher rate of tobacco abstinence than depressed patients who did not achieve remission (MADRS >/= 8).

Condition Intervention
Drug: Varenicline

MedlinePlus related topics: Depression Smoking
Drug Information available for: Varenicline
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment
Official Title: Varenicline for Smoking Cessation in Bipolar Depressed Patients: An Open-Label 12-Week Feasibility Trial

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • The primary outcome measure is a 7-day point prevalence self-report abstinence rate confirmed by expired breath CO < 10 ppm. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A secondary analysis will evaluate abstinence rates based on index mood state (major depression vs. depressive symptoms) and final visit mood state status (remission vs. non-remission). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Varenicline
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • Currently on mood stabilization treatment a minimum daily therapeutic dosage of at least one mood stabilizer [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]. Antidepressants are not exclusionary. 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).
  • Agree to identify collateral individuals for contact purposes to facilitate follow-up appointments

Exclusion Criteria:

  • 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 the MontgomeryAsberg Depression Scale (MADRS) question #10 > 4) or any screening question on the Scale for Suicide Ideation answered affirmatively (i.e. active desire to die or commit suicide).
  • History of medically serious suicide attempt.
  • 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)
  • 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
  Contacts and Locations
Please refer to this study by its identifier: NCT00813800

Contact: Cindy J. Stoppel 507-284-5914

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Mark A. Frye, M.D. Mayo Clinic
  More Information

Mayo Clinic Clinical Trials  This link exits the site

Responsible Party: Mayo Clinic ( Mark Frye, MD )
Study ID Numbers: 08-003471
Study First Received: December 22, 2008
Last Updated: December 22, 2008 Identifier: NCT00813800  
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

Study placed in the following topic categories:
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Habits processed this record on January 13, 2009