Childhood-onset schizophrenia. A double-blind clozapine-haloperidol comparison

UMMS Affiliation

Department of Psychiatry

Publication Date


Document Type



Adolescent; Age Factors; Age of Onset; Child; Child, Preschool; Clozapine; Double-Blind Method; Drug Administration Schedule; Haloperidol; Humans; Neutropenia; Psychiatric Status Rating Scales; Schizophrenia, Childhood; Seizures; Severity of Illness Index; Treatment Outcome




BACKGROUND: Childhood-onset schizophrenia is a rare but severe form of the disorder that is often treatment-refractory. In this study, the efficacy and adverse effects of clozapine and haloperidol were compared for children and adolescents with early-onset schizophrenia.

METHODS: Twenty-one patients (mean [+/-SD] age, 14.0 +/- 2.3 years) with onset of Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition-defined schizophrenia that began by age 12 years and who had been nonresponsive to typical neuroleptics participated in the study. Patients were randomized to a 6-week double-blind parallel comparison of clozapine (mean [+/-SD] final dose, 176 +/- 149 mg/d), or haloperidol, (16 +/- 8 mg/d).

RESULTS: Clozapine was superior to haloperidol on all measures of psychosis (P = .04-.002). Positive and negative symptoms of schizophrenia improved. However, neutropenia and seizures were major concerns. To date, one third of the group has discontinued using clozapine.

CONCLUSIONS: Clozapine has striking superiority for positive and negative symptoms in treatment-refractory childhood-onset schizophrenia. However, due to possibly increased toxic effects in this pediatric population, close monitoring for adverse events is essential.


Arch Gen Psychiatry. 1996 Dec;53(12):1090-7.

Journal/Book/Conference Title

Archives of general psychiatry

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