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Treatment of Nicotine Dependence and Acute Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00186446
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Alan Schatzberg, Stanford University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Major Depressive Disorder
Nicotine Dependence
Intervention: Drug: bupropion and smoking cessation behavioral intervention

  Participant Flow

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
Bupropion and Smoking Cessation Behavioral Intervention Medication for depression and behavioral intervention for smoking cessation

Participant Flow:   Overall Study
    Bupropion and Smoking Cessation Behavioral Intervention
STARTED   20 
COMPLETED   11 
NOT COMPLETED   9 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Bupropion and Smoking Cessation Behavioral Intervention No text entered.

Baseline Measures
   Bupropion and Smoking Cessation Behavioral Intervention 
Overall Participants Analyzed 
[Units: Participants]
 		 20 
Age 
[Units: Years]
Mean (Standard Deviation) 		 44.35  (10.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      10  50.0% 
Male      10  50.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants 		 
American Indian or Alaska Native      0   0.0% 
Asian      2  10.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      17  85.0% 
More than one race      0   0.0% 
Unknown or Not Reported      1   5.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants 		 
United States   20 


  Outcome Measures

1.  Primary:   Hamilton Depression Scale Score   [ Time Frame: baseline to week 10 ]
  Show Outcome Measure 1

2.  Primary:   Cessation of Smoking   [ Time Frame: Week 10 ]
  Show Outcome Measure 2

3.  Primary:   Can Depression and Smoking Cessation be Treated Simultaneously   [ Time Frame: Dropouts over course of study ]
  Show Outcome Measure 3


  Serious Adverse Events


  Other Adverse Events


  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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  More Information

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.


Results Point of Contact:  
Name/Title: aimee-noelle swanson
Organization: Stanford University
phone: 650-736-4559
e-mail: aimnoe@stanford.edu



Responsible Party: Alan Schatzberg, Stanford University
ClinicalTrials.gov Identifier: NCT00186446     History of Changes
Other Study ID Numbers: GSK 103341
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: October 18, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017