NCT00000390

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2000

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2000

First QC Date

January 17, 2000

Last Update Submit

April 22, 2015

Conditions

Depression

Keywords

AdultAcquired Immunodeficiency SyndromeDepressionFemaleHumanImipramineMaleMiddle AgeAcquired Immunodeficiency Syndrome -- *complicationsDepression -- *drug therapyDepression -- etiologyImipramine -- *therapeutic use

Interventions

Imipramine hydrochlorideDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Hosp - Cornell Med Ctr

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

DepressionAcquired Immunodeficiency Syndrome

Interventions

Imipramine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Frances A

    STUDY CHAIR

  • Manning D

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 17, 2000

First Posted

January 18, 2000

Last Updated

April 23, 2015

Record last verified: 2000-04

Locations

US(1)