Conditions

Bipolar I Disorder Schizophrenia

Keywords

safetyschizophreniabipolar I (manic or mixed)adolescentsweight management

Outcome Measures

Primary Outcomes (1)

Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants
Baseline, 52 weeks

Secondary Outcomes (7)

Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months
Baseline, 52 weeks
Time to Event for 7%, 15%, and 25% Weight Gain for All Participants
Baseline up to 52 weeks
Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder
Baseline, 52 weeks
Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants
52 weeks
Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants
Baseline, 52 weeks
+2 more secondary outcomes

Study Arms (2)

Olanzapine/standard behavioral weight intervention

EXPERIMENTAL

Drug: OlanzapineBehavioral: Standard behavioral weight intervention

Olanzapine/intense behavioral weight intervention

EXPERIMENTAL

Drug: OlanzapineBehavioral: Intense behavioral weight intervention

Interventions

OlanzapineDRUG

2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks

Also known as: Zyprexa, LY170053

Olanzapine/intense behavioral weight interventionOlanzapine/standard behavioral weight intervention

Standard behavioral weight interventionBEHAVIORAL

One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only.

Olanzapine/standard behavioral weight intervention

Intense behavioral weight interventionBEHAVIORAL

Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits.

Olanzapine/intense behavioral weight intervention

Eligibility Criteria

Age13 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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.

You may not qualify if:

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.
+5 more criteria

Contact the study team to confirm eligibility.