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Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers

Primary Purpose

Depressive Disorder, Smoking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fixed dose varenicline
varenicline
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring varenicline, depression, anhedonia, smoking

Eligibility Criteria

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

Inclusion Criteria:

  1. Meets DSM-IV symptoms criteria for a mood disorder including major depression [unipolar or bipolar], depressive disorder NOS, dysthymia, adjustment disorder with depressed mood, or substance-induced mood disorder.
  2. Failed to achieve full symptom remission with previous pharmacotherapy.
  3. Current tobacco users.
  4. Able to give written, informed consent.

Exclusion Criteria:

  1. Past adverse reaction to varenicline.
  2. Renal failure or dialysis.
  3. Current pregnancy or breastfeeding.

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

varenicline

Arm Description

open label varenicline

Outcomes

Primary Outcome Measures

Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report
this is a 16-item self report questionnaire that measures depressive symptoms. Improvement is reported in change in depressive score score ranges from 0-27, with higher numbers indicating more severe symptom reporting. change is calculated by baseline plus/minus the value at the later time point

Secondary Outcome Measures

Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)
Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al, 1995). The SHAPS is a 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the "disagree" responses score one point, and either of the "agree" responses score 0 points. Thus, the final score ranges from 0 to 14. The SHAPS has adequate construct validity and satisfactory test-retest reliability (ICC=0.70) (Franken et al, 2007). High internal consistency has also been reported (Cronbach's alpha of 0.94) (Franken et al, 2007)
Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI)
Reference: Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville, MD, U.S. Department of Health, Education, and Welfare The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).

Full Information

First Posted
September 4, 2007
Last Updated
October 30, 2018
Sponsor
Butler Hospital
Collaborators
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT00525837
Brief Title
Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers
Official Title
Systematic Assessment of Response to Open-label Treatment With Varenicline in Depressed Outpatient Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
Brown University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess whether varenicline (chantix) has antidepressant properties when used in addition to other psychiatric medication. It will also assess whether varenicline improves the inability to feel pleasure (i.e. anhedonia), and if it is well-tolerated when used with psychiatric medications. Enrolled patients will be assessed for improved mood, improved anhedonia, overall sense of health, side effects as well as tobacco use for 6-8 weeks. Medication will be provided free of charge.
Detailed Description
Outpatient smokers who are depressed despite current stable psychiatric medication regimens will be invited to participate. They will receive varenicline dosed according to FDA-approved smoking cessation regime; patients will be assessed using QIDS-SR16, snaith-hamilton anhedonia rating scale, SAFTEE and clinical global improvement self-report scales and clinician global improvement scales at the above time intervals. Concurrent medication, psychiatric and non-psychiatric, will be recorded, as will vital signs (BP, HR, weight) and tobacco use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Smoking
Keywords
varenicline, depression, anhedonia, smoking

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
varenicline
Arm Type
Other
Arm Description
open label varenicline
Intervention Type
Drug
Intervention Name(s)
fixed dose varenicline
Other Intervention Name(s)
Chantix
Intervention Description
varenicline 0.5 mg po daily for days 1-3, 0.5 twice daily for days 4-7, 1 mg twice daily thereafter for study duration.
Intervention Type
Drug
Intervention Name(s)
varenicline
Other Intervention Name(s)
Chantix
Intervention Description
up to 1 mg twice daily
Primary Outcome Measure Information:
Title
Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report
Description
this is a 16-item self report questionnaire that measures depressive symptoms. Improvement is reported in change in depressive score score ranges from 0-27, with higher numbers indicating more severe symptom reporting. change is calculated by baseline plus/minus the value at the later time point
Time Frame
Baseline and every 2 weeks until 8 weeks or study endpoint
Secondary Outcome Measure Information:
Title
Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)
Description
Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al, 1995). The SHAPS is a 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the "disagree" responses score one point, and either of the "agree" responses score 0 points. Thus, the final score ranges from 0 to 14. The SHAPS has adequate construct validity and satisfactory test-retest reliability (ICC=0.70) (Franken et al, 2007). High internal consistency has also been reported (Cronbach's alpha of 0.94) (Franken et al, 2007)
Time Frame
6-8 weeks
Title
Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI)
Description
Reference: Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville, MD, U.S. Department of Health, Education, and Welfare The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).
Time Frame
6-8 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: Meets DSM-IV symptoms criteria for a mood disorder including major depression [unipolar or bipolar], depressive disorder NOS, dysthymia, adjustment disorder with depressed mood, or substance-induced mood disorder. Failed to achieve full symptom remission with previous pharmacotherapy. Current tobacco users. Able to give written, informed consent. Exclusion Criteria: Past adverse reaction to varenicline. Renal failure or dialysis. Current pregnancy or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah S Philip, MD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence H Price, MD
Organizational Affiliation
Butler Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19323966
Citation
Philip NS, Carpenter LL, Tyrka AR, Whiteley LB, Price LH. Varenicline augmentation in depressed smokers: an 8-week, open-label study. J Clin Psychiatry. 2009 Jul;70(7):1026-31. doi: 10.4088/jcp.08m04441. Epub 2009 Mar 24.
Results Reference
derived

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Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers

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