study in adolescents with schizophrenia or bipolar disorder

Conditions: Bipolar I Disorder; Schizophrenia

Summary: open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years, with bipolar i disorder (manic or mixed episodes) or schizophrenia.


Eligibility criteria:
inclusion criteria: * participants must have a diagnosis of bipolar i disorder and display an acute manic or mixed episode (with or without psychotic features) or a diagnosis of schizophrenia according to the diagnostic and statistical manual of mental disorders, fourth edition - text revision (dsm-iv-tr)and confirmed by the kiddie schedule for affective disorders and schizophrenia for school aged children-present and lifetime (k-sads-pl). * participants with a diagnosis of schizophrenia must obtain a brief psychiatric rating scale for children (bprs-c) total score \>30, with a minimum score of 3 on at least one of the following items at both screening and randomization - hallucinations, delusions, peculiar fantasies. * participants with a diagnosis of bipolar i disorder must have a young mania rating scale (ymrs) total score greater than or equal to 15 at both screening and randomization. * has given assent (when applicable); and has a parent or authorized legal representative who has given informed consent, is reliable, has a level of understanding sufficient to permit participant to perform all tests and examinations required by the protocol, and understands the nature of the study. exclusion criteria: * history of mental retardation, current comorbid autism, or current comorbid pervasive developmental disorder. * have dsm-iv-tr substance (except nicotine and caffeine) dependence within the past 30 days prior to randomization. * been judged clinically to be at any suicidal risk. * history of allergic reaction or hypersensitivity to olanzapine. * receiving current pharmaceutical treatment for weight management or are participating in a structured behavioral diet and/or exercise weight loss program. * other antipsychotics, mood stabilizers, or anticonvulsants (for mood stabilization) used for the primary study conditions (bipolar i disorder or schizophrenia) * have acute, serious, or unstable medical conditions * have any illness such that death is anticipated within 1 year or intensive care unit hospitalization for the illness is anticipated within 12 months (365 days). * have had one or more seizures without a clear and resolved etiology. * baseline alanine aminotransferase (alt) values greater than or equal to 2 times the upper limit of normal (uln) of the performing laboratory or aspartate aminotransferase (ast) values greater than or equal to 2 times the uln or total bilirubin values greater than or equal to 1.5 times the uln at screening. * have leukopenia or history of leukopenia without a clear and resolved etiology or known history of agranulocytosis (absolute neutrophil count \<500 cubic millimeter \[mm\^3\], \<0.5 gi/l, or \<0.5 10e\^3/microliters \[μl\]) during the participant's lifetime. * prolactin level of \>200 nanograms per milliliter (ng/ml) \[\>200 micrograms per liter (ug/l), or \>4228 milli-international unit per liter (miu/l)\] at screening. * have qtc (bazett's) \>450 milliseconds (males) or \>460 milliseconds (females) at screening. * previously been randomized in this study and/or participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to screening. * currently prescribed olanzapine for greater than or equal to 5 days within 1 month (30 days) prior to screening. * are investigator site personnel directly affiliated with this study and/or their immediate families or are employed by or representatives of lilly. * pregnant or nursing. * have received treatment within the last 30 days with an investigational new drug that has not received regulatory approval for any indication at the time of study entry. * treatment with clozapine within 14 days prior to randomization. * participants who have used olanzapine (that is, oral olanzapine, intramuscular \[im\] olanzapine, or olanzapine orally disintegrating tablets) and have had treatment withdrawn due to clinically significant and/or intolerable adverse effects, or who have exhibited a lack of efficacy/response to treatment to olanzapine including treatment resistance.

Keywords: safety schizophrenia bipolar i (manic or mixed) adolescents weight management