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Treatment of Nicotine Dependence and Acute Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186446
First Posted: September 16, 2005
Last Update Posted: April 4, 2017
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.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Alan Schatzberg, Stanford University
September 13, 2005
September 16, 2005
October 18, 2016
April 4, 2017
April 4, 2017
June 2004
September 2007   (Final data collection date for primary outcome measure)
  • Hamilton Depression Scale Score [ Time Frame: baseline to week 10 ]
    Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher values indicate more depression. % Change in depression score from baseline to week 10. Negative values indicate a reduction in depression.
  • Cessation of Smoking [ Time Frame: Week 10 ]
    Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.
  • Can Depression and Smoking Cessation be Treated Simultaneously [ Time Frame: Dropouts over course of study ]
    This was measured by the drop out rate during the study.
We hope to learn whether or not it is safe to target both smoking cessation and acute depression concurrently, without adversely affecting treatment outcomes for either disorder.
Complete list of historical versions of study NCT00186446 on ClinicalTrials.gov Archive Site
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Treatment of Nicotine Dependence and Acute Depression
Treatment of Nicotine Dependence and Acute Depression
The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same time, along with a brief behavioral intervention for smoking cessation.
The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same time, along with a brief behavioral intervention for smoking cessation.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Major Depressive Disorder
  • Nicotine Dependence
Drug: bupropion and smoking cessation behavioral intervention
Experimental: Bupropion
Intervention: Drug: bupropion and smoking cessation behavioral intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2007
September 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age at least 18 at the beginning of the study
  • Smoking at least 10 cigarettes a day (1/2 pack)
  • Meets DSM-IV criteria for major depressive episode

Exclusion Criteria:

  • Currently pregnant
  • Currently breastfeeding
  • Currently diagnosed with a seizure disorder, liver disease, kidney disease, congestive heart failure or diabetes mellitis
  • History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
  • Family history of seizures
  • Currently using intravenous drugs
  • Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
  • Currently using any over-the-counter stimulants and anorectics (diet pills)
  • Currently on fluoxetine (Prozac), bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL) or any other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
  • Currently on NRT or bupropion (Zyban)
  • Current or past diagnosis of anorexia nervosa
  • Previous allergic response to fluoxetine, bupropion, or NRT
  • Previous failed quit attempt using NRT and bupropion in combination
  • Current suicidal ideation
  • Current or past psychosis, mania/hypomania, or any other Axis I or Axis II psychiatric diagnosis other than major depression and nicotine dependence
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00186446
GSK 103341
Not Provided
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Not Provided
Alan Schatzberg, Stanford University
Stanford University
GlaxoSmithKline
Study Director: Anna Lembke, MD Stanford University
Stanford University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP