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NCT Number: NCT00525837

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

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.

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Key information

Conditions

Depressive Disorder Anhedonia Behavior Behavioral Symptoms Depression Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Smoking

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fixed dose varenicline

Drug

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 names: Chantix

Varenicline

Drug

up to 1 mg twice daily

Other names: Chantix

Primary outcomes

  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 outcomes

  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

    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).

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • Brown University

Registry information

Official study title

Systematic Assessment of Response to Open-label Treatment With Varenicline in Depressed Outpatient Smokers

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 6, 2007
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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