Antidepressant Treatment of AIDS Related Depression.

Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000390
• Other study ID #: R01MH042952
• Secondary ID: 87-DEP
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2000
• Last updated: April 22, 2015

Study information

• Verified date: April 2000
• Source: National Institute of Mental Health (NIMH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Imipramine hydrochloride

Locations

Country	Name	City	State
United States	New York Hosp - Cornell Med Ctr	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
GEIGY Pharmaceuticals

Country where clinical trial is conducted

United States,