NCT00018642

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1997

Longer than P75 for not_applicable schizophrenia

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2001

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
Last Updated

January 21, 2009

Status Verified

December 1, 2004

First QC Date

July 3, 2001

Last Update Submit

January 20, 2009

Conditions

Keywords

quetiapinehaloperidol decanoate

Interventions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Schizophrenia or Schizoaffective Disorder diagnosed by DSM-IV
  • Between the ages 18-60.
  • 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.

You may not qualify if:

  • Organic brain disease.
  • Mental Retardation
  • Chronic medical illness which would make antipsychotic medication inappropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Quetiapine Fumaratehaloperidol decanoate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

July 3, 2001

First Posted

July 5, 2001

Study Start

April 1, 1997

Study Completion

March 1, 2002

Last Updated

January 21, 2009

Record last verified: 2004-12

Locations