Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers - Full Text View

Sponsor:	Butler Hospital
Collaborator:	Brown University
Information provided by:	Butler Hospital
ClinicalTrials.gov Identifier:	NCT00525837

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:

MedlinePlus related topics: Depression Smoking

Drug Information available for: Varenicline Varenicline tartrate

U.S. FDA Resources

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:

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.

Contacts and Locations

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):

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.

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
Smoking
Mood Disorders
Mental Disorders
Behavioral Symptoms
Habits
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 February 09, 2012