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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00018642
Other study ID # MHBS-042-96F
Secondary ID
Status Completed
Phase N/A
First received July 3, 2001
Last updated January 20, 2009
Start date April 1997
Est. completion date March 2002

Study information

Verified date December 2004
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to determine whether a new drug for schizophrenia is better for the maintenance treatment than a standard drugs currently prescribed. The new medication is called quetiapine and it will be compared with a standard medication called haloperidol decanoate. The study will determine if quetiapine causes fewer problems than haloperidol with side effects such as stiffness and restlessness and whether it costs the VA more or less to treat patients with quetiapine. In addition, blood samples will be collected every three months to determine if certain chemicals in the blood can influence the outcome of the subjects' illness.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date March 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria

1. Schizophrenia or Schizoaffective Disorder diagnosed by DSM-IV

2. Between the ages 18-60.

3. A candidate for maintenance antipsychotic therapy. This means that patients will have had at least two documented episodes of acute schizophrenic illness or at least two years of continuing psychotic symptoms.

Exclusion Criteria

1. Organic brain disease.

2. Mental Retardation

3. Chronic medical illness which would make antipsychotic medication inappropriate.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment


Intervention

Drug:
quetiapine

haloperidol decanoate


Locations

Country Name City State
United States VA Greater Los Angeles Healthcare System Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

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