NCT00169065

Brief Summary

This study will determine the effectiveness of clozapine versus olanzapine in treating people with schizophrenia that has not improved with treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Aug 1998

Typical duration for phase_4 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

3.8 years

First QC Date

September 10, 2005

Last Update Submit

April 6, 2015

Conditions

Schizophrenia

Keywords

Clozapineolanzapine

Outcome Measures

Primary Outcomes (1)

  • Changes in quality of life.

Secondary Outcomes (1)

  • Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family.

Study Arms (2)

Clozapine

ACTIVE COMPARATOR

Clozapine or olanzapine in treatment resistant schizophrenia

Drug: Clozapine

olanzapine

ACTIVE COMPARATOR

clozapine or olanzapine in treatment resistant schizophrenia

Drug: Olanzapine

Interventions

ClozapineDRUG
Clozapine
OlanzapineDRUG
olanzapine

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-60 years;
  • Diagnosis of treatment refractory schizophrenia or schizoaffective disorder;
  • BPRS score \> 21 (0-6) scale;
  • Either two 6-8 week trials of typical neuroleptics given at a dosage of 600 mg/day of CPZ or its equivalent or one 6-8 week trial of an atypical antipsychotic at a reasonable dose (i.e. risperidone 4-6 mg/day);
  • The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent;
  • Clinically appropriate for clozapine or olanzapine

You may not qualify if:

  • Current substance abuse;
  • Suicide or homicide risk;
  • Pregnancy or lactation;
  • History of seizures or blood dyscrasias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Commonwealth Research Center

Jamaica Plain, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

ClozapineOlanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-Ring

Study Officials

  • Alan I Green, MD

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

August 1, 1998

Primary Completion

June 1, 2002

Study Completion

June 1, 2002

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(1)