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Antidepressant Treatment of AIDS Related Depression.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000390
First Posted: January 18, 2000
Last Update Posted: April 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Mental Health (NIMH)
January 17, 2000
January 18, 2000
April 23, 2015
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Complete list of historical versions of study NCT00000390 on ClinicalTrials.gov Archive Site
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Antidepressant Treatment of AIDS Related Depression.
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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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Depression
Drug: Imipramine hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
  • 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
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Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00000390
R01MH042952( U.S. NIH Grant/Contract )
87-DEP ( Other Identifier: GEIGY Pharmaceuticals )
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GEIGY Pharmaceuticals
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Study Chair: Frances A
Study Chair: Manning D
National Institute of Mental Health (NIMH)
April 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP