Overview

Study in Adolescents With Schizophrenia or Bipolar Disorder

Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Olanzapine
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.