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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupropion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupropion and smoking cessation behavioral intervention | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale Score | 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. | baseline to week 10 |
| Cessation of Smoking | Carbon monoxide breath level of below 9PPM which indicates cessation of smoking. | Week 10 |
| Can Depression and Smoking Cessation be Treated Simultaneously | This was measured by the drop out rate during the study. | Dropouts over course of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Lembke, MD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupropion and Smoking Cessation Behavioral Intervention | Medication for depression and behavioral intervention for smoking cessation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupropion and Smoking Cessation Behavioral Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hamilton Depression Scale Score | 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. | 9 patients did not complete the study and we used last observation carried forward | Posted | Mean | Standard Deviation | percentage of change in depression | baseline to week 10 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupropion and Smoking Cessation Behavioral Intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| aimee-noelle swanson | Stanford University | 650-736-4559 | aimnoe@stanford.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Primary | Cessation of Smoking | Carbon monoxide breath level of below 9PPM which indicates cessation of smoking. | Carbon monoxide levels available on 8 subjects at week 10. | Posted | Count of Participants | Participants | Week 10 |
|
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| Primary | Can Depression and Smoking Cessation be Treated Simultaneously | This was measured by the drop out rate during the study. | Number dropped out of the study | Posted | Count of Participants | Participants | Dropouts over course of study |
|
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|
| 0 |
| 20 |
| 0 |
| 20 |
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| D064419 |
| Chemically-Induced Disorders |