Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

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: NCT00525837
Recruitment Status : Completed
First Posted : September 6, 2007
Results First Posted : May 23, 2011
Last Update Posted : November 28, 2018
Brown University
Information provided by (Responsible Party):
Butler Hospital

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Smoking Drug: fixed dose varenicline Drug: varenicline Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Systematic Assessment of Response to Open-label Treatment With Varenicline in Depressed Outpatient Smokers
Study Start Date : September 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
open label varenicline
Drug: fixed dose varenicline
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.
Other Name: Chantix

Drug: varenicline
up to 1 mg twice daily
Other Name: Chantix

Primary Outcome Measures :
  1. Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report [ Time Frame: Baseline and every 2 weeks until 8 weeks or study endpoint ]

    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 :
  1. Improvement on Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: 6-8 weeks ]
    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)

  2. Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI) [ Time Frame: 6-8 weeks ]


    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00525837

Layout table for location information
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Brown University
Layout table for investigator information
Principal Investigator: Noah S Philip, MD Butler Hospital
Study Director: Lawrence H Price, MD Butler Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Butler Hospital Identifier: NCT00525837    
Other Study ID Numbers: 0707-002
First Posted: September 6, 2007    Key Record Dates
Results First Posted: May 23, 2011
Last Update Posted: November 28, 2018
Last Verified: October 2018
Keywords provided by Butler Hospital:
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Mood Disorders
Mental Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs