NCT00007774

Brief Summary

Although currently marketed antipsychotic drugs are useful in the treatment of schizophrenia, efficacy and safety profiles need to be improved. Forty to eighty percent of patients either fail to respond or only partially respond to conventional antipsychotic agents. Secondary symptoms may be unimproved even in patients who respond to treatment. A variety of adverse events occur in patients receiving currently available agents. The severity of these events contributes to the poor compliance that is observed in this patient population. Olanzapine is a novel antipsychotic agent with a reduced incidence of extrapyramidal symptoms. Other side effects are minimal.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

18 active sites

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

Study Start

First participant enrolled

March 1, 1998

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 1, 2001

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

Enrollment Period

3.3 years

First QC Date

December 29, 2000

Last Update Submit

February 3, 2009

Conditions

Schizoaffective DisorderSchizophrenia

Keywords

Olanzapine, haloperidol, schizophrenia, schisoaffe

Study Arms (2)

1

EXPERIMENTAL

Olanzapine

Drug: Olanzapine

2

ACTIVE COMPARATOR

Haloperidol

Drug: Haloperidol

Interventions

HaloperidolDRUG
2
OlanzapineDRUG
1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with schizophrenia or schizoaffective disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

VA Medical Center, Tuscaloosa

Tuscaloosa, Alabama, 35404, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

VA Medical Center, Bay Pines

Bay Pines, Florida, 33708, United States

Location

VA Medical Center, Miami

Miami, Florida, 33125, United States

Location

VA Medical Center, Augusta

Augusta, Georgia, 30904, United States

Location

Richard Roudebush VA Medical Center, Indianapolis

Indianapolis, Indiana, 46202-2884, United States

Location

VA Maryland HCS, Perry Point Division

Perry Point, Maryland, 21902, United States

Location

Edith Nourse Rogers Memorial Veterans Hospital, Bedford

Bedford, Massachusetts, 01730, United States

Location

John D. Dingell VA Medical Center, Detroit

Detroit, Michigan, 48201, United States

Location

VA New Jersey Health Care System, East Orange

East Orange, New Jersey, 07018, United States

Location

New Mexico VA Health Care System, Albuquerque

Albuquerque, New Mexico, 87108-5153, United States

Location

Franklin Delano Roosevelt Campus, VA Hudson Valley HCS

Montrose, New York, 10548, United States

Location

New York Harbor HCS

New York, New York, 10010, United States

Location

VA Medical Center, Durham

Durham, North Carolina, 27705, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

VA Pittsburgh Health Care System

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (2)

  • Perlick DA, Rosenheck RA, Kaczynski R, Bingham S, Collins J. Association of symptomatology and cognitive deficits to functional capacity in schizophrenia. Schizophr Res. 2008 Feb;99(1-3):192-9. doi: 10.1016/j.schres.2007.08.009. Epub 2007 Sep 12.

    PMID: 17851042RESULT

  • Rosenheck R, Perlick D, Bingham S, Liu-Mares W, Collins J, Warren S, Leslie D, Allan E, Campbell EC, Caroff S, Corwin J, Davis L, Douyon R, Dunn L, Evans D, Frecska E, Grabowski J, Graeber D, Herz L, Kwon K, Lawson W, Mena F, Sheikh J, Smelson D, Smith-Gamble V; Department of Veterans Affairs Cooperative Study Group on the Cost-Effectiveness of Olanzapine. Effectiveness and cost of olanzapine and haloperidol in the treatment of schizophrenia: a randomized controlled trial. JAMA. 2003 Nov 26;290(20):2693-702. doi: 10.1001/jama.290.20.2693.

    PMID: 14645311RESULT

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Interventions

HaloperidolOlanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Robert A. Rosenheck, AB MD

    VA Connecticut Health Care System (West Haven)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Masking
DOUBLE
Sponsor Type
FED

Study Record Dates

First Submitted

December 29, 2000

First Posted

January 1, 2001

Study Start

March 1, 1998

Primary Completion

June 1, 2001

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations

US(18)