Major Depressive DisorderPhase 4NCT00186446
Treatment of Nicotine Dependence and Acute Depression
A Phase 4 study testing bupropion and smoking cessation behavioral intervention in people with Major Depressive Disorder and Nicotine Dependence, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Nicotine Dependence
- What is being tested?
- bupropion and smoking cessation behavioral intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Sep 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Nicotine Dependence
- Being tested
- bupropion and smoking cessation behavioral intervention
- Medical subject headings
- Depressive Disorder, Major, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropion and smoking cessation behavioral interventionDrug
| Study group | Role | What they receive |
|---|---|---|
| Bupropion | Experimental | Not described Receives: Drug: bupropion and smoking cessation behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to week 10
Cessation of Smoking
Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.
Measured: Week 10
Can Depression and Smoking Cessation be Treated Simultaneously
This was measured by the drop out rate during the study.
Measured: Dropouts over course of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Alan Schatzberg, Stanford University
- Investigators
- Anna Lembke, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186446
- Sponsor's protocol ID
- GSK 103341
- Status last verified
- Feb 2017
- First submitted
- 13 Sep 2005
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Nicotine Dependence and Acute Depression
- ClinicalTrials.gov ID
- NCT00186446
- Acronym / sponsor ID
- GSK 103341
- Conditions
- Major Depressive Disorder, Nicotine Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bupropion | Experimental | Drug: bupropion and smoking cessation behavioral intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupropion and smoking cessation behavioral intervention | Drug | Bupropion |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Lembke, MD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bupropion and smoking cessation behavioral intervention in people with Major Depressive Disorder and Nicotine Dependence, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale Score (time frame: baseline to week 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.