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

This study has been completed.
Sponsor:
Collaborator:
Brown University
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00525837
First received: September 4, 2007
Last updated: June 2, 2011
Last verified: June 2011
  Purpose

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 Intervention
Depressive Disorder
Smoking
Drug: fixed dose varenicline
Drug: varenicline

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Systematic Assessment of Response to Open-label Treatment With Varenicline in Depressed Outpatient Smokers

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report [ Time Frame: Baseline and every 2 weeks until 8 weeks or study endpoint ] [ Designated as safety issue: No ]

    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 Anhedonia Scale [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
  • Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI) [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
  • Tolerability of Varenicline Measured by Adverse Symptoms Checklist (SAFTEE-SI LCN Modified) [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: September 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
varenicline
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

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.

  Eligibility

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525837

Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Brown University
Investigators
Principal Investigator: Noah S Philip, MD Butler Hospital
Study Director: Lawrence H Price, MD Butler Hospital
  More Information

No publications provided by Butler Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lawrence H. Price, M.D., Butler Hospital
ClinicalTrials.gov Identifier: NCT00525837     History of Changes
Other Study ID Numbers: 0707-002
Study First Received: September 4, 2007
Results First Received: October 4, 2010
Last Updated: June 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Butler Hospital:
varenicline
depression
anhedonia
smoking

Additional relevant MeSH terms:
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014