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Varenicline in Bipolar Depressed Patients (Varenicline)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00813800
Recruitment Status : Completed
First Posted : December 23, 2008
Results First Posted : January 30, 2012
Last Update Posted : January 30, 2012
Information provided by (Responsible Party):
Mark Frye, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE December 22, 2008
First Posted Date  ICMJE December 23, 2008
Results First Submitted Date  ICMJE November 11, 2011
Results First Posted Date  ICMJE January 30, 2012
Last Update Posted Date January 30, 2012
Study Start Date  ICMJE January 2009
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2011)
Carbon Monoxide Breath Level at 12 Weeks [ Time Frame: 12 weeks ]
Measured by expired breath in parts per million (ppm)
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2011)
  • Montgomery-Asberg Depression Rating Scale (MADRS) at 12 Weeks [ Time Frame: 12 weeks ]
    MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item on the MADRS is scaled 0 through 6. Lowest score = 0, would indicate no depressive symptoms. Highest score = 60, indicating extreme depression. MADRS score > 20 is syndromal depression. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134:382-389.
  • Young Mania Rating Scale (YMRS) at 12 Weeks [ Time Frame: 12 weeks ]
    YMRS is an eleven-item, multiple choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes in patients already diagnosed with mania. Lowest score = 0, normal subject; Highest score = 60, highly manic subject. For this scale the following scores are associated with these grades of severity: mania (YMRS = 20), hypomania (YMRS = 12), under 5 is classified as non-manic. Young RC, Biggs JT, Ziegler Ve, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. BR J Psychiatry 1978; 133:429-435.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Varenicline in Bipolar Depressed Patients
Official Title  ICMJE Varenicline for Smoking Cessation in Bipolar Depressed Patients: An Open-Label 12-week Feasibility Trial
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%.
Detailed Description

Varenicline, a nicotinic acetylcholine receptor partial agonist, has been shown in two placebo-controlled trials to be efficacious for smoking cessation. Given the high prevalence of nicotine dependence in bipolar disorder and the high prevalence of sub-syndromal and syndromal depressive symptoms in bipolar disorder, this 12-week adjunctive varenicline open label trial will be conducted to assess the feasibility, acceptability, and safety of varenicline in bipolar depressed smokers. All subjects will receive individual behavioral counseling.

Primary hypothesis: the abstinence rate for bipolar depressed patients will be 50%. Secondary hypothesis: 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Smoking
  • Bipolar Disorder
  • Depression
Intervention  ICMJE 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.
Other Name: Chantix
Study Arms  ICMJE Experimental: Varenicline
Open-label; subjects will receive a behavioral intervention in addition to Varenicline.
Intervention: Drug: Varenicline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2011)
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2008)
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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
    • Antidepressants are not exclusionary.
    • 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).]

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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00813800
Other Study ID Numbers  ICMJE 08-003471
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark Frye, Mayo Clinic
Study Sponsor  ICMJE Mark Frye
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Mark A. Frye, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP