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

B

Butler Hospital

Status

Completed

Conditions

Smoking
Depressive Disorder

Treatments

Drug: varenicline
Drug: fixed dose varenicline

Study type

Interventional

Funder types

Other

Identifiers

NCT00525837
0707-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

varenicline
Other group
Description:
open label varenicline
Treatment:
Drug: fixed dose varenicline
Drug: varenicline

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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