NCT00048828

Brief Summary

This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

3 active sites

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

October 1, 2001

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2002

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2002

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

4.7 years

First QC Date

November 8, 2002

Last Update Submit

July 1, 2013

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Psychotic, manic, aggressive, and depressive symptoms

    Measured over 12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Olanzapine

2

ACTIVE COMPARATOR
Drug: Clozapine

Interventions

OlanzapineDRUG

Participants will receive olanzapine for 12 weeks.

1
ClozapineDRUG

Participants will receive 12 weeks of clozapine.

2

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • DSM-IV criteria for treatment-refractory schizophrenia or schizoaffective disorder
  • Willingness to use an acceptable form of birth control, if applicable

You may not qualify if:

  • Neurological or medical disorders that would contraindicate treatment with clozapine or olanzapine
  • IQ less than 70
  • DSM-IV criteria for substance (other than caffeine or nicotine) related disorder
  • Failure of an adequate trial of olanzapine or clozapine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sagamore Children's Psychiatric Center

Dix Hills, New York, 11746, United States

Location

Long Island Jewish Medical Center

Glen Oaks, New York, 11004, United States

Location

Bronx Children's Psychiatric Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

OlanzapineClozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDibenzazepinesHeterocyclic Compounds, 3-Ring

Study Officials

  • Christoph U. Correll, MD

    The Zucker Hillside Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2002

First Posted

November 13, 2002

Study Start

October 1, 2001

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

US(3)