Major Depressive Disorder, Nicotine Dependence
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGbupropion and smoking cessation behavioral intervention
Sponsors
GlaxoSmithKline
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Scale Score | 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 | Week 10 | Carbon monoxide breath level of below 9PPM which indicates cessation of smoking. |
| Can Depression and Smoking Cessation be Treated Simultaneously | Dropouts over course of study | This was measured by the drop out rate during the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupropion and Smoking Cessation Behavioral Intervention | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Bupropion and Smoking Cessation Behavioral Intervention |
|---|---|
| Age, Continuous | 44.35 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Can Depression and Smoking Cessation be Treated Simultaneously
This was measured by the drop out rate during the study.
Time frame: Dropouts over course of study
Population: Number dropped out of the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupropion and Smoking Cessation Behavioral Intervention | Can Depression and Smoking Cessation be Treated Simultaneously | 9 Participants |
Primary
Cessation of Smoking
Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.
Time frame: Week 10
Population: Carbon monoxide levels available on 8 subjects at week 10.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupropion and Smoking Cessation Behavioral Intervention | Cessation of Smoking | 7 Participants |
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.
Time frame: baseline to week 10
Population: 9 patients did not complete the study and we used last observation carried forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupropion and Smoking Cessation Behavioral Intervention | Hamilton Depression Scale Score | -.5322 percentage of change in depression | Standard Deviation 0.27 |
p-value: <0.001t-test, 2 sided