We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)
  Purpose

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 Intervention Phase
Depression Drug: Imipramine hydrochloride Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000390


Locations
United States, New York
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
  More Information

ClinicalTrials.gov Identifier: NCT00000390     History of Changes
Other Study ID Numbers: R01MH042952 ( U.S. NIH Grant/Contract )
87-DEP ( Other Identifier: GEIGY Pharmaceuticals )
First Submitted: January 17, 2000
First Posted: January 18, 2000
Last Update Posted: April 23, 2015
Last Verified: April 2000

Keywords provided by National Institute of Mental Health (NIMH):
Adult
Acquired Immunodeficiency Syndrome
Depression
Female
Human
Imipramine
Male
Middle Age
Acquired Immunodeficiency Syndrome -- *complications
Depression -- *drug therapy
Depression -- etiology
Imipramine -- *therapeutic use

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Imipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs