Study in Adolescents With Schizophrenia or Bipolar Disorder
Condition: Bipolar I Disorder; Schizophrenia
MeSH terms: Schizophrenia
Intervention: Olanzapine; Standard behavioral weight intervention; Intense behavioral weight intervention
Intervention description: 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks; One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only.; 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.
Intervention MeSH terms: Olanzapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 203.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: safety; schizophrenia; bipolar I (manic or mixed); adolescents; weight management

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.