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Varenicline in Bipolar Depressed Patients (Varenicline)

Primary Purpose

Smoking, Bipolar Disorder, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Varenicline
Sponsored by
Mark Frye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring Smoking, Bipolar Disorder, Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Varenicline

Arm Description

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

Outcomes

Primary Outcome Measures

Carbon Monoxide Breath Level at 12 Weeks
Measured by expired breath in parts per million (ppm)

Secondary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS) at 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
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.

Full Information

First Posted
December 22, 2008
Last Updated
December 23, 2011
Sponsor
Mark Frye
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00813800
Brief Title
Varenicline in Bipolar Depressed Patients
Acronym
Varenicline
Official Title
Varenicline for Smoking Cessation in Bipolar Depressed Patients: An Open-Label 12-week Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Frye
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Bipolar Disorder, Depression
Keywords
Smoking, Bipolar Disorder, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Varenicline
Arm Type
Experimental
Arm Description
Open-label; subjects will receive a behavioral intervention in addition to Varenicline.
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Carbon Monoxide Breath Level at 12 Weeks
Description
Measured by expired breath in parts per million (ppm)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS) at 12 Weeks
Description
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.
Time Frame
12 weeks
Title
Young Mania Rating Scale (YMRS) at 12 Weeks
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A. Frye, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

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Varenicline in Bipolar Depressed Patients

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