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A Prospective, Open-Label Trial of Olanzapine in Adolescents With Schizophrenia

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ABSTRACT

Background

Olanzapine is an atypical antipsychotic that has efficacy in adults with psychotic disorders. This preliminary study examined the effectiveness of olanzapine in adolescents with schizophrenia or its related conditions.

Method

Adolescents aged 12–17 years (inclusive) with a diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder were enrolled in this 8-week, open-label, outpatient study. The Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impressions Scale (CGI), and the Children's Global Assessment Scale (CGAS) were administered as outcome measures. Extrapyramidal side effects were assessed at each visit. Olanzapine was initiated at a dose of 2.5 mg/day and could be increased to a maximum total daily dose of 20 mg.

Results

Sixteen participants with a mean age of 13.8 (SD = 1.5) years were treated. Significant improvements were found in the PANSS, CGI severity, and CGAS scores. Reductions in both positive and negative symptoms were found. Increased appetite and sedation were the most frequently reported side effects. Two subjects required treatment for extrapyramidal side effects.

Conclusions

Psychotic symptoms significantly improved during study. Overall, olanzapine was well tolerated. Future studies are needed to confirm these findings, to assess long-term treatment outcomes, and to compare the effectiveness of olanzapine with that of other antipsychotics.

Section snippets

METHOD

This study was an 8-week, open-label, prospective outpatient trial of olanzapine in adolescents with a schizophrenia spectrum disorder in which the subjects were seen biweekly. Subjects were recruited from within the auspices of the clinical and research infrastructures within a midwestern academic division of child and adolescent psychiatry. The Institutional Review Board for Human Investigation at University Hospitals of Cleveland approved the procedures that were performed under the auspices

RESULTS

Seventeen subjects signed informed consent and were enrolled in this trial. One of these subjects withdrew consent before the baseline visit. Therefore, 16 subjects were actually administered study medication. All data reported herein are based on these 16 teenagers.

DISCUSSION

Overall, olanzapine was well tolerated and was associated with amelioration of both positive and negative psychotic symptoms in this outpatient population. However, patients did have residual symptoms at study's end. Strengths of this study include its diagnostic homogeneous patient population, its emphasis on a community-based cohort, its prospective design, and its 8-week duration.

Besides being complementary to the available information regarding the use of olanzapine in

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    From the Departments of Psychiatry and Pediatrics, Case Western Reserve University School of Medicine and University Hospitals of Cleveland and the Department of Psychiatry, University of Minnesota, Minneapolis.

    This study was primarily sponsored by Eli Lilly and was supported in part by a Clinical Research Center Grant from the Stanley Medical Research Institute.

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