Study in Adolescents With Schizophrenia or Bipolar Disorder

Lilly

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Bipolar I Disorder

Treatments

Drug: Olanzapine

Behavioral: Standard behavioral weight intervention

Behavioral: Intense behavioral weight intervention

Study type

Interventional

Funder types

Industry

Identifiers

NCT00982020

F1D-MC-HGMX (Other Identifier)

12117

Details and patient eligibility

About

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.

Enrollment

203 patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

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.