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

This study has been completed.

Study NCT00525837 Information provided by Butler Hospital

First Received on September 4, 2007. Last Updated on June 2, 2011 History of Changes

Results First Received: October 4, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Depressive Disorder Smoking
Interventions:	Drug: fixed dose varenicline Drug: varenicline

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Varenicline	No text entered.

Participant Flow: Overall Study

	Varenicline
STARTED	18
COMPLETED	14
NOT COMPLETED	4

Baseline Characteristics

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Reporting Groups

	Description
Varenicline	No text entered.

Baseline Measures

	Varenicline
Number of Participants [units: participants]	18
Age [units: years] Mean ± Standard Deviation	47.8 ± 10.1
Age, Customized [units: participants]
Between 18 and 65 years	18
Gender [units: participants]
Female	12
Male	6
Region of Enrollment [units: participants]
United States	18

Outcome Measures

1. Primary:

Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report [ Time Frame: Baseline and every 2 weeks until 8 weeks or study endpoint ]

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2. Secondary:

Improvement on Snaith-Hamilton Anhedonia Scale [ Time Frame: 6-8 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI) [ Time Frame: 6-8 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Tolerability of Varenicline Measured by Adverse Symptoms Checklist (SAFTEE-SI LCN Modified) [ Time Frame: 6-8 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Noah S. Philip MD
Organization: Butler Hospital
phone: 401-455-6258
e-mail: noah_philip@brown.edu

No publications provided by Butler Hospital

Publications automatically indexed to this study:

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