Phase 4
N=203
Study in Adolescents With Schizophrenia or Bipolar Disorder
Bipolar I Disorder · Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00982020 ↗Enrolled (actual)
203
Serious AEs
16.3%
Results posted
Dec 2014
Primary outcome: Primary: Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants — 3.64; 2.83 kilograms per meter squared (kg/m^2) — p=0.150
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Olanzapine (Drug); Standard behavioral weight intervention (Behavioral); Intense behavioral weight intervention (Behavioral)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants |
3.64; 2.83 | 0.150 |
| SECONDARY Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months |
3.36; 2.99 | 0.520 |
| SECONDARY Time to Event for 7%, 15%, and 25% Weight Gain for All Participants |
57; 57; 197; 198; NA; NA | — |
| SECONDARY Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder |
-17.66; -12.05 | 0.008 sig |
| SECONDARY Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants |
2.04; 2.29 | 0.266 |
| SECONDARY Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants |
7.22; 7.31 | 0.954 |
| SECONDARY Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants |
-2.06; -1.74 | 0.103 |
| SECONDARY Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia |
-28.00; -30.96 | 0.436 |
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 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.
Data sourced from ClinicalTrials.gov (NCT00982020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.