- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000390
Antidepressant Treatment of AIDS Related Depression.
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 Overview
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 Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10021
- New York Hosp - Cornell Med Ctr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Frances A
- Study Chair: Manning D
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Adrenergic Uptake Inhibitors
- Imipramine
Other Study ID Numbers
- R01MH042952 (NIH)
- 87-DEP (OTHER: GEIGY Pharmaceuticals)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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