MedPath

Antidepressant Treatment of AIDS Related Depression.

Phase 2
Completed
Conditions
Depression
Registration Number
NCT00000390
Lead Sponsor
GEIGY Pharmaceuticals
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

New York Hosp - Cornell Med Ctr

🇺🇸

New York, New York, United States

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