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

This study has been completed.
Sponsor:
Collaborator:
Brown University
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00525837
First received: September 4, 2007
Last updated: June 2, 2011
Last verified: June 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
No text entered.

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 ]
  Show Outcome Measure 1

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:


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