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

September 4, 2007
June 2, 2011
September 2007
March 2008   (final data collection date for primary outcome measure)
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

Improvement on quick inventory of depressive symptoms, 16 question self-report. [ Time Frame: 6-8 weeks ]
Complete list of historical versions of study NCT00525837 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Improvement on Snaith-Hamilton anhedonia scale [ Time Frame: 6-8 weeks ]
  • Improvement on patient and clinician clinical global impression rating scale (CGI) [ Time Frame: 6-8 weeks ]
  • Tolerability of varenicline measured by adverse symptoms checklist (SAFTEE-SI LCN modified) [ Time Frame: 6-8 weeks ]
Not Provided
Not Provided
 
Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers
Systematic Assessment of Response to Open-label Treatment With Varenicline 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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depressive Disorder
  • Smoking
  • 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
varenicline
open label varenicline
Interventions:
  • Drug: fixed dose varenicline
  • Drug: varenicline
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. Epub 2009 Mar 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00525837
0707-002
No
Lawrence H. Price, M.D., Butler Hospital
Butler Hospital
Brown University
Principal Investigator: Noah S Philip, MD Butler Hospital
Study Director: Lawrence H Price, MD Butler Hospital
Butler Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP