Study in Adolescents With Schizophrenia or Bipolar Disorder



Status:Completed
Conditions:Schizophrenia, Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:October 2009
End Date:May 2013
Contact:There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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A Long-Term, Open-Label, Safety Study of Oral Olanzapine in Adolescents With Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia


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.


Inclusion Criteria:

- Patients 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 and confirmed by the Kiddie Schedule for
Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime
(K-SADS-PL).

- Patients 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.

- Patients 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 patient 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 (ie, 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 mm3, <0.5 GI/L, or
<0.5 10E3/μL) during the patient's lifetime.

- Prolactin level of >200 ng/mL (>200 ug/L, or >4228 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.

- Patients 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.
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