Varenicline in Bipolar Depressed Patients - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00813800

Purpose

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
Smoking Bipolar Depression	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:

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

Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT00813800

Contacts

Contact: Cindy J. Stoppel

507-284-5914

stoppel.cynthia@mayo.edu

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Mark A. Frye, M.D.

Mayo Clinic

More Information

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

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

Keywords provided by Mayo Clinic:

Smoking
Bipolar
Depression

Study placed in the following topic categories:

Smoking
Depression
Mental Disorders

Mood Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on January 13, 2009