Back to resultsAntidepressant Treatment of AIDS Related Depression.
Primary Purpose
Depression
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Imipramine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Adult, Acquired Immunodeficiency Syndrome, Depression, Female, Human, Imipramine, Male, Middle Age, Acquired Immunodeficiency Syndrome -- *complications, Depression -- *drug therapy, Depression -- etiology, Imipramine -- *therapeutic use
Eligibility Criteria
Inclusion Criteria: Patient must be ambulatory and relatively good health. Even if unable to work at least able to partially care care for self and not demented. May have been alcoholic or drug abuser 6 months previous. Unspecified CD4 Unspecified. Exclusion Criteria: Non ambulatory patients or those requiring extensive help in self care are excluded. Non ambulatory patients or those requiring extensive help in self care are excluded. Current alcohol or drug abuse. Unspecified
Sites / Locations
- New York Hosp - Cornell Med Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00000390
Brief Title
Antidepressant Treatment of AIDS Related Depression.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2000
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GEIGY Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
To test the effectiveness treating AIDS related depression with imipramine hydrochloride.
Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status.
This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over phase in which placebo non responders are entered into an open-label study and given imipramine hydrochloride.
Detailed Description
To test the effectiveness treating AIDS related depression with imipramine hydrochloride.
Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status.
This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over phase in which placebo non responders are entered into an open-label study and given imipramine hydrochloride.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Adult, Acquired Immunodeficiency Syndrome, Depression, Female, Human, Imipramine, Male, Middle Age, Acquired Immunodeficiency Syndrome -- *complications, Depression -- *drug therapy, Depression -- etiology, Imipramine -- *therapeutic use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Imipramine hydrochloride
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
Patient must be ambulatory and relatively good health. Even if unable to work at least able to partially care care for self and not demented.
May have been alcoholic or drug abuser 6 months previous.
Unspecified
CD4 Unspecified.
Exclusion Criteria:
Non ambulatory patients or those requiring extensive help in self care are excluded.
Non ambulatory patients or those requiring extensive help in self care are excluded.
Current alcohol or drug abuse.
Unspecified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances A
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Manning D
Official's Role
Study Chair
Facility Information:
Facility Name
New York Hosp - Cornell Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Antidepressant Treatment of AIDS Related Depression.
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