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Childhood Onset Psychotic Disorders: Characterization and Treatment With Atypical Neuroleptics
Sponsor study identifier
Secondary identifiers
interventional
25
1 country
1
Study Start
June 1997
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)The purpose of this study is to compare the effectiveness and side effects of the drugs clozapine and olanzapine in children and adolescents with schizophrenia and psychoses. Childhood psychosis is a serious disorder that may have devastating consequences. Effective treatments for the condition are under continual investigation. This study will examine the causes of and offer treatment for childhood psychosis. Participants in this study will undergo psychological tests, blood and urine tests, electroencephalogram (EEG), electrocardiogram (EKG), and magnetic resonance imaging (MRI) scans of the brain for the first 1 to 2 weeks of the study while taking their regular medications. Participants will then be tapered off their medications over 1 to 3 weeks and will continue to stay off medications for an additional 2 days to 3 weeks. During this time, participants will undergo psychiatric, neurological, and cardiac examinations as well as blood tests. After this period without medications, participants will be randomly assigned to receive either clozapine or olanzapine for 8 weeks. An EEG will be performed prior to treatment and after 6 weeks of study medication. Participants who respond well to the study drugs may continue to receive them through their own physician. Participants who do not respond to either clozapine or olanzapine or cannot tolerate their side effects will be treated individually with other drugs until optimum treatment is identified. Regular telephone updates and in person visits to NIH for repeat testing and MRIs will be conducted.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1997
Date type not reportedThis date has not been verified as actual or estimated.
November 3, 1999
Actual (reported)November 4, 1999
Actual (reported)June 2008
Actual (reported)June 2008
Actual (reported)April 12, 2011
Actual (reported)Change in the Scale for the Assessment of Negative Symptoms
Measures change in affective flattening or blunting, alogia, avolition/apathy, anhedonia/asociality, attention; minimum score = 0; maximum score = 125; lower values are considered a better outcome
8 week double-blind study period; baseline and 8 weeks
Change in the Clinical Global Impression Severity of Symptoms Scale
Measures change in the severity of symptoms; Minimum score = 1; maximum score = 7; lower score is considered a better outcome.
8 week double-blind study period; baseline and 8 weeks
Change in the Brief Psychiatric Rating Scale-24
A 24-item scale measuring change in interpersonal behaviors, mood, psychosis, anxiety, speech, sleep, orientation and physical activity. Lowest score = 24; highest score = 168; lower score is considered a better outcome.
tablet; 5-20mg/day; 8 weeks
tablet; 12.5-900mg/day; 8 weeks
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Gordon CT, Frazier JA, McKenna K, Giedd J, Zametkin A, Zahn T, Hommer D, Hong W, Kaysen D, Albus KE, et al. Childhood-onset schizophrenia: an NIMH study in progress. Schizophr Bull. 1994;20(4):697-712. doi: 10.1093/schbul/20.4.697.
Nicolson R, Rapoport JL. Childhood-onset schizophrenia: rare but worth studying. Biol Psychiatry. 1999 Nov 15;46(10):1418-28. doi: 10.1016/s0006-3223(99)00231-0.
Shaw P, Sporn A, Gogtay N, Overman GP, Greenstein D, Gochman P, Tossell JW, Lenane M, Rapoport JL. Childhood-onset schizophrenia: A double-blind, randomized clozapine-olanzapine comparison. Arch Gen Psychiatry. 2006 Jul;63(7):721-30. doi: 10.1001/archpsyc.63.7.721.
Judith L Rapoport, M.D.
Child Psychiatry Branch, NIMH, NIH
25 participants (actual enrollment reported by the registry).
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
June 1997
Date type not reportedThis date has not been verified as actual or estimated.
8 week double-blind study period; baseline and 8 weeks
Change in the Scale for the Assessment of Positive Symptoms
Measures change in hallucinations, delusions, bizarre behavior, and thought organization. Minimum score = 0; maximum score = 170; lower score is considered a better outcome.
8 week double-blind study period; baseline and 8 weeks
Change in the Bunney-Hamburg Rating Scale for Psychosis
Measures change in psychosis severity; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.
8 week double-blind study period; baseline and 8 weeks
Change in Bunney-Hamburg Rating Scale for Depression
Measures change in severity of depression; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.
8 week double-blind study period; baseline and 8 weeks
Change in Bunney-Hamburg Rating Scale for Mania
Measures change in the severity of mania; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.
8 week double-blind study period; baseline and 8 weeks
Change in the Bunney-Hamburg Rating Scale for Anxiety
Measures change in the severity of anxiety; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.
8 week double-blind study period; baseline and 8 weeks
Change in Weight
8 week double-blind study period; baseline and 8 weeks
Change in Body Mass Index (BMI)
8 week double-blind study period; baseline and 8 weeks
Change in Extrapyramidal Movements as Measured by the Abnormal Involuntary Movements Scale (AIMS)
8 week double-blind study period; baseline and 8 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)Last Updated
April 12, 2011
Results First Posted
April 12, 2011
Record last verified: 2011-03
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Source: ClinicalTrials.gov.
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