Antidepressant Treatment of AIDS Related Depression.

Sponsor
GEIGY Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00000390
Collaborator
(none)
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Imipramine hydrochloride
Phase 2

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York Hosp - Cornell Med Ctr New York New York United States 10021

    Sponsors and Collaborators

    • GEIGY Pharmaceuticals

    Investigators

    • Study Chair: Frances A,
    • Study Chair: Manning D,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00000390
    Other Study ID Numbers:
    • R01MH042952
    • 87-DEP
    First Posted:
    Jan 18, 2000
    Last Update Posted:
    Apr 23, 2015
    Last Verified:
    Apr 1, 2000

    Study Results

    No Results Posted as of Apr 23, 2015