Antidepressant Treatment of AIDS Related Depression. | NCT00000390

Studies
Antidepressant Treatment of AIDS Related Depression.

NCT00000390

Sponsor

GEIGY Pharmaceuticals

Status

Completed

Last Update Posted

Apr 23, 2015Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Depression

Interventions

Imipramine hydrochloride

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
87-DEP	Other Identifier	GEIGY Pharmaceuticals

Status Module

Record Verification Date

Apr 2000

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 17, 2000

First Submission Date that Met QC Criteria

Jan 17, 2000

First Posted Date

Jan 18, 2000Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2015

Last Update Posted Date

Apr 23, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

GEIGY PharmaceuticalsINDUSTRY

Collaborators

Not provided

Description Module

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.

Conditions Module

Conditions

Depression

Keywords

Adult
Acquired Immunodeficiency Syndrome
Depression
Female
Human
Imipramine
Male
Middle Age
Acquired Immunodeficiency Syndrome -- *complications
Depression -- *drug therapy
Depression -- etiology
Imipramine -- *therapeutic use

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Imipramine hydrochloride	Drug

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frances A		Study Chair
Manning D		Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York Hosp - Cornell Med Ctr		New York	New York	10021	United States

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D015658	HIV Infections
D000086982	Blood-Borne Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007099	Imipramine

Ancestor Terms

ID	Term
D003984	Dibenzazepines
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided