Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449007
Status:
TERMINATED
Last Update Posted:
2021-08-04
First Post:
2007-03-15
Brief Title:
Fluoxetine and Bupropion to Treat Patients With Depression and Alcoholism
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment of this population was not feasible
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH Grant P20 AA015630-02 | US NIH GrantContract | None | httpsreporternihgovquickSearchP20AA015630 |
| P20AA015630 | NIH | None | None |