NCT00525837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

May 23, 2011

Completed
Last Updated

November 28, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

September 4, 2007

Results QC Date

October 4, 2010

Last Update Submit

October 30, 2018

Conditions

Depressive DisorderSmoking

Keywords

vareniclinedepressionanhedoniasmoking

Outcome Measures

Primary Outcomes (1)

  • Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report

    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

    Baseline and every 2 weeks until 8 weeks or study endpoint

Secondary Outcomes (2)

  • Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)

    6-8 weeks

  • Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI)

    6-8 weeks

Study Arms (1)

varenicline

OTHER

open label varenicline

Drug: fixed dose vareniclineDrug: varenicline

Interventions

fixed dose vareniclineDRUG

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.

Also known as: Chantix
varenicline
vareniclineDRUG

up to 1 mg twice daily

Also known as: Chantix
varenicline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Past adverse reaction to varenicline.
  • Renal failure or dialysis.
  • Current pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • 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.

    PMID: 19323966DERIVED

MeSH Terms

Conditions

Depressive DisorderSmokingDepressionAnhedonia

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehaviorBehavioral SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Results Point of Contact

Title
Noah S. Philip MD
Organization
Butler Hospital
noah_philip@brown.edu
401-455-6258

Study Officials

  • Noah S Philip, MD

    Butler Hospital

    PRINCIPAL INVESTIGATOR

  • Lawrence H Price, MD

    Butler Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 6, 2007

Study Start

September 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

November 28, 2018

Results First Posted

May 23, 2011

Record last verified: 2018-10

Locations

US(1)