Status:
TERMINATED
Fluoxetine and Bupropion to Treat Patients With Depression and Alcoholism
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Depression
Alcoholism
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 ...
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 clin...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00449007
Start Date
February 1 2006
End Date
December 1 2010
Last Update
August 4 2021
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032