ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Antidepressant Treatment of AIDS Related Depression.

This study has been completed.
Study NCT00000390.   Last updated on June 23, 2005.   Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Antidepressant Treatment of AIDS Related Depression.
Official Title 
Brief 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.

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 Phase Phase II
Study Type  Interventional
Study Design  Treatment, Placebo Control
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Depression
Intervention  Drug: Imipramine hydrochloride
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
Eligibility 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
Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000390
Organization ID 87-DEP
Secondary IDs ††
Study Sponsor  GEIGY Pharmaceuticals
Collaborators ††
Investigators 
Study Chair:     Frances A        
Study Chair:     Manning D        
Information Provided By National Institute of Mental Health (NIMH)
Verification Date April 2000
First Received Date  January 17, 2000
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers