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

NCT ID: NCT00525837

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-03-31

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.

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.

Conditions

Depressive Disorder; Smoking

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

varenicline

open label varenicline

Group Type: OTHER

fixed dose varenicline

Intervention Type: 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.

varenicline

Intervention Type: DRUG

up to 1 mg twice daily

Interventions

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.

Intervention Type: DRUG

varenicline

up to 1 mg twice daily

Intervention Type: DRUG

Other Intervention Names

Chantix; Chantix

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noah S Philip, MD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Lawrence H Price, MD

Role: STUDY_DIRECTOR

Butler Hospital

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

References

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. doi: 10.4088/jcp.08m04441. Epub 2009 Mar 24.

Reference Type: DERIVED

PMID: 19323966 (View on PubMed)

Other Identifiers

0707-002

Identifier Type: -

Identifier Source: org_study_id