Antidepressant Treatment of AIDS Related Depression.

NCT ID: NCT00000390

Last Updated: 2015-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Imipramine hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GEIGY Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Frances A

Role: STUDY_CHAIR

Manning D

Role: STUDY_CHAIR

Locations

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New York Hosp - Cornell Med Ctr

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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87-DEP

Identifier Type: OTHER

Identifier Source: secondary_id

R01MH042952

Identifier Type: NIH

Identifier Source: org_study_id

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