Treating Drug-Resistant Childhood Schizophrenia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00048828 |
Recruitment Status
:
Completed
First Posted
: November 13, 2002
Last Update Posted
: July 2, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: Olanzapine Drug: Clozapine | Phase 4 |
Schizophrenia is a devastating illness regardless of the age at which it presents. When this disorder occurs in childhood or adolescence, the consequences in terms of functional impairment, loss of developmental opportunities, and family and societal burden are particularly dramatic.
Evidence supports the improved efficacy and/or side effect profile of atypical antipsychotic medication in adults. Thus, it is essential to examine whether the potential benefits of these agents can be extended to children, particularly children who have failed standard treatment.
Patients are randomly assigned to receive either clozapine or olanzapine daily for 12 weeks. Patients meet with the study team once a week to discuss progress and record side effects. Three parent meetings take place during the study. During these meetings, questions are discussed and support and education about schizophrenia are given to parents. Various scales to measure psychotic, manic, aggressive, and depressive symptoms are used to assess patients.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Treating Refractory Childhood Schizophrenia |
Study Start Date : | October 2001 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1 |
Drug: Olanzapine
Participants will receive olanzapine for 12 weeks.
|
Active Comparator: 2 |
Drug: Clozapine
Participants will receive 12 weeks of clozapine.
|
- Psychotic, manic, aggressive, and depressive symptoms [ Time Frame: Measured over 12 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 10 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- DSM-IV criteria for treatment-refractory schizophrenia or schizoaffective disorder
- Willingness to use an acceptable form of birth control, if applicable
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048828
United States, New York | |
Bronx Children's Psychiatric Center | |
Bronx, New York, United States, 10461 | |
Sagamore Children's Psychiatric Center | |
Dix Hills, New York, United States, 11746 | |
Long Island Jewish Medical Center | |
Glen Oaks, New York, United States, 11004 |
Principal Investigator: | Christoph U. Correll, MD | The Zucker Hillside Hospital |
Responsible Party: | Christoph U. Correll, MD, The Zucker Hillside Hospital |
ClinicalTrials.gov Identifier: | NCT00048828 History of Changes |
Other Study ID Numbers: |
R01MH060229 ( U.S. NIH Grant/Contract ) DSIR 84-CTM |
First Posted: | November 13, 2002 Key Record Dates |
Last Update Posted: | July 2, 2013 |
Last Verified: | July 2013 |
Additional relevant MeSH terms:
Schizophrenia Schizophrenia, Childhood Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Neurodevelopmental Disorders Olanzapine Clozapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Serotonin Antagonists GABA Antagonists GABA Agents |