DepressionPhase 4NCT00449007
Fluoxetine and Bupropion to Treat Patients With Depression and Alcoholism
A Phase 4 study testing fluoxetine and bupropion in people with Depression and Alcoholism, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
We will study patients with a current major depressive episode, comorbid alcoholism and a history of a past suicide attempt. All subjects with alcohol dependence will be evaluated for risk of alcohol withdrawal prior to randomization. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Alcoholism, Suicidal Behavior
- What is being tested?
- fluoxetine and bupropion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Dec 2010
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient suffering from a major depressive episode (unipolar only) AND alcohol dependence or abuse; Score of greater than 16 on the HDRS
- Age range 18-65 years
- History of a past suicide attempt, defined as self destructive behavior with at least some intent to die; patients with suicidal plan or intent will only be enrolled as inpatients if staff agrees it is reasonable.
- Able to tolerate cross taper to study medications
Who cannot join
- Other major psychiatric disorders such as Bipolar Disorder; schizophrenia or schizoaffective disorder, past or current psychotic symptoms; eating disorder; substance abuse or dependence (other than alcohol, caffeine or nicotine); persons already taking SSRIs or bupropion for other indications such as anxiety disorders.
- Primary disorder is an anxiety disorder such as Panic disorder/GAD/OCD/Social anxiety disorder, with secondary depression.
- CIWA-AR rating >10 or history of delirium tremens or seizures.
- Blood pressure >150 systolic or >90 diastolic
- Active or untreated medical problems
- Antipsychotic medication required
Show all 11Show fewer
- History of becoming hypomanic or manic on antidepressants
- Contraindication to the use of fluoxetine or bupropion, or currently using Zyban
- Failure to respond to adequate trials of 3 SSRIs or fluoxetine or bupropion in the last 2 years (failure to respond to therapeutic trial defined as: at least 2/3 maximal PDR dose for at least 6 weeks)
- Lack of capacity to consent
- Pregnancy, lactation, or plans to conceive during the course of study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: A Randomized Controlled Study Comparing Fluoxetine With Bupropion for Impulsivity and Suicidality in Patients With Major Depressive Disorder and Comorbid Alcoholism (Abuse or Dependence)
We will study patients with a current major depressive episode, comorbid alcoholism and a history of a past suicide attempt. All subjects with alcohol dependence will be evaluated for risk of alcohol withdrawal prior to randomization. The study will provide six months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention. Patients will also be encouraged to attend daily Alcoholics Anonymous meetings. The outcome measures will be: 1) occurrence of suicide events; 2) reduction of suicidal ideation; 3) reduction in neuropsychological measures of impulsivity.
Read the detailed description
Suicide is a significant public health problem. Depression, alcoholism (abuse or dependence), and a prior suicide attempt are risk factors for suicide. However, little information exists to guide clinicians in the choice of antidepressant medication for patients with comorbid major depression and alcoholism who are at risk for suicidal acts.
There is evidence that selective serotonin reuptake inhibitors (SSRI) may reduce impulsive aggression, and therefore lower the risk for suicidal behavior. We will test the hypothesis that fluoxetine, an SSRI, will be associated with fewer suicide events (defined as suicidal acts or increases in suicidal ideation necessitating a change in management), decreased suicidal ideation and decreases in neuropsychological measures of impulsivity compared to bupropion. The non-serotonergic drug, bupropion will improve energy and hopelessness. We expect the two drugs to be equally efficacious in reducing global depression severity. We will compare fluoxetine with bupropion in a 6-month randomized, controlled study of major depressive disorder and comorbid alcoholism in patients who have a prior history of suicide attempt. Patients requiring alcohol detoxification will be excluded. Patients will also receive weekly psychotherapy.
We will study 42 subjects with a current major depressive episode, comorbid alcoholism and a history of a past suicide attempt (21 subjects per year) in a randomized, double-blind, controlled trial, stratified by alcoholism type (1 vs 2). All subjects with alcohol dependence will be evaluated for risk of alcohol withdrawal prior to randomization. We will include patients who have suicidal ideation. However, patients with a suicidal plan or intent will only be enrolled as inpatients if the research team and the independent treatment team on the inpatient research unit agree that this is clinically reasonable. For example, if ECT or antipsychotics are indicated, the patient will not be enrolled. The study will provide six months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention. Patients will also be encouraged to attend daily Alcoholics Anonymous meetings. The outcome measures will be: 1) occurrence of suicide events; 2) reduction of suicidal ideation; 3) reduction in neuropsychological measures of impulsivity.
- Conditions
- Depression, Alcoholism, Suicidal Behavior
- Being tested
- fluoxetine, bupropion
- Keywords
- Major depressive disorder, Alcohol abuse, Alcohol dependence, Suicide
- Medical subject headings
- Depression, Alcoholism, Depressive Disorder, Major, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoxetineDrug
6 months
bupropionDrug
6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | fluoxetine -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings Receives: Drug: fluoxetine |
| 2 | Active comparator | bupropion -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings Receives: Drug: bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Suicide Events Either a Suicide Death, a Suicide Attempt, or Suicidal Ideation Severe Enough to Warrant a Medical Intervention
patients have either a suicide death, a suicide attempt, or suicidal ideation severe enough to warrant a medical intervention. this is assessed using the Columbia Suicide History Form and a consensus conference rules on whether the event meets criteria or not. Medical interventions can include hospitalization, a change in medication (adding adjunctive meds) or an increase in frequency of visits or other methods to monitor the patient.
The range is 0 and up and denotes the number of suicide events (not the number of participants and not the number of suicide attempts). Higher score is worse and predicts future suicidal behavior
Measured: 6 months
Secondary outcomes (1)
Suicidal Ideation at 6 Months
Participant Score on the Scale for Suicidal Ideation will be the outcome variable.
The SSI range is from 0-38 and higher score is worse and may predict suicide risk
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startFeb 2006
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: recruitment of this population was not feasible
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 DepressionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Maria A. Oquendo, MD, Principal investigator, NYS Psychiatric Institute / Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449007
- Sponsor's protocol ID
- NIAAA-OQU-015630-02
- Other IDs
- P20AA015630, NIH Grant P20 AA015630-02
- Status last verified
- Jul 2021
- First submitted
- 15 Mar 2007
- Last updated
- 4 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing Fluoxetine With Bupropion for Impulsivity and Suicidality in Patients With Major Depressive Disorder and Comorbid Alcoholism (Abuse or Dependence)
- ClinicalTrials.gov ID
- NCT00449007
- Acronym / sponsor ID
- NIAAA-OQU-015630-02
- Conditions
- Depression, Alcoholism, Suicidal Behavior
- Keywords
- Major depressive disorder, Alcohol abuse, Alcohol dependence, Suicide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment of this population was not feasible
- Enrolment
- 5 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Mar 2007 (estimated)
- Results
- Posted 16 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will study patients with a current major depressive episode, comorbid alcoholism and a history of a past suicide attempt. All subjects with alcohol dependence will be evaluated for risk of alcohol withdrawal prior to randomization. The study will provide six months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention. Patients will also be encouraged to attend daily Alcoholics Anonymous meetings. The outcome measures will be: 1) occurrence of suicide events; 2) reduction of suicidal ideation; 3) reduction in neuropsychological measures of impulsivity.
Detailed description
Suicide is a significant public health problem. Depression, alcoholism (abuse or dependence), and a prior suicide attempt are risk factors for suicide. However, little information exists to guide clinicians in the choice of antidepressant medication for patients with comorbid major depression and alcoholism who are at risk for suicidal acts.
There is evidence that selective serotonin reuptake inhibitors (SSRI) may reduce impulsive aggression, and therefore lower the risk for suicidal behavior. We will test the hypothesis that fluoxetine, an SSRI, will be associated with fewer suicide events (defined as suicidal acts or increases in suicidal ideation necessitating a change in management), decreased suicidal ideation and decreases in neuropsychological measures of impulsivity compared to bupropion. The non-serotonergic drug, bupropion will improve energy and hopelessness. We expect the two drugs to be equally efficacious in reducing global depression severity. We will compare fluoxetine with bupropion in a 6-month randomized, controlled study of major depressive disorder and comorbid alcoholism in patients who have a prior history of suicide attempt. Patients requiring alcohol detoxification will be excluded. Patients will also receive weekly psychotherapy.
We will study 42 subjects with a current major depressive episode, comorbid alcoholism and a history of a past suicide attempt (21 subjects per year) in a randomized, double-blind, controlled trial, stratified by alcoholism type (1 vs 2). All subjects with alcohol dependence will be evaluated for risk of alcohol withdrawal prior to randomization. We will include patients who have suicidal ideation. However, patients with a suicidal plan or intent will only be enrolled as inpatients if the research team and the independent treatment team on the inpatient research unit agree that this is clinically reasonable. For example, if ECT or antipsychotics are indicated, the patient will not be enrolled. The study will provide six months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention. Patients will also be encouraged to attend daily Alcoholics Anonymous meetings. The outcome measures will be: 1) occurrence of suicide events; 2) reduction of suicidal ideation; 3) reduction in neuropsychological measures of impulsivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: fluoxetinefluoxetine -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings |
| 2 | Active comparator | Drug: bupropionbupropion -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient suffering from a major depressive episode (unipolar only) AND alcohol dependence or abuse; Score of greater than 16 on the HDRS
- Age range 18-65 years
- History of a past suicide attempt, defined as self destructive behavior with at least some intent to die; patients with suicidal plan or intent will only be enrolled as inpatients if staff agrees it is reasonable.
- Able to tolerate cross taper to study medications
Key exclusion criteria (11 listed)
- Other major psychiatric disorders such as Bipolar Disorder; schizophrenia or schizoaffective disorder, past or current psychotic symptoms; eating disorder; substance abuse or dependence (other than alcohol, caffeine or nicotine); persons already taking SSRIs or bupropion for other indications such as anxiety disorders.
- Primary disorder is an anxiety disorder such as Panic disorder/GAD/OCD/Social anxiety disorder, with secondary depression.
- CIWA-AR rating >10 or history of delirium tremens or seizures.
- Blood pressure >150 systolic or >90 diastolic
- Active or untreated medical problems
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 |
|---|---|---|
| fluoxetine6 months | Drug | 1 |
| bupropion6 months | Drug | 2 |
Primary outcome
Occurrence of Suicide Events Either a Suicide Death, a Suicide Attempt, or Suicidal Ideation Severe Enough to Warrant a Medical Intervention
Time frame: 6 months
patients have either a suicide death, a suicide attempt, or suicidal ideation severe enough to warrant a medical intervention. this is assessed using the Columbia Suicide History Form and a consensus conference rules on whether the event meets criteria or not. Medical interventions can include hospitalization, a change in medication (adding adjunctive meds) or an increase in frequency of visits or other methods to monitor the patient. The range is 0 and up and denotes the number of suicide events (not the number of participants and not the number of suicide attempts). Higher score is worse and predicts future suicidal behavior
1 secondary outcome
Suicidal Ideation at 6 Months
Time frame: 6 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- 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.
Maria A. Oquendo, MD principal investigator
NYS Psychiatric Institute / Columbia 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 fluoxetine and bupropion in people with Depression and Alcoholism, run by New York State Psychiatric Institute 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 4 Aug 2021. 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 16 Jul 2021). 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?
Occurrence of Suicide Events Either a Suicide Death, a Suicide Attempt, or Suicidal Ideation Severe Enough to Warrant a Medical Intervention (time frame: 6 months). 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 Aug 2021.