Antidepressant Treatment of AIDS Related Depression. - Full Text View

Sponsor:	GEIGY Pharmaceuticals
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00000390

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 II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Antidepressants Depression HIV/AIDS

Drug Information available for: Imipramine Imipramine hydrochloride

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

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.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier:	NCT00000390 History of Changes
Other Study ID Numbers:	87-DEP
Study First Received:	January 17, 2000
Last Updated:	June 23, 2005
Health Authority:	Unspecified

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:

Acquired Immunodeficiency Syndrome
Depression
Depressive Disorder
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Behavioral Symptoms
Mood Disorders

Mental Disorders
Antidepressive Agents
Imipramine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012