Study in Adolescents With Schizophrenia or Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00982020
First received: September 15, 2009
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Bipolar I Disorder
Schizophrenia
Drug: Olanzapine
Behavioral: Standard behavioral weight intervention
Behavioral: Intense behavioral weight intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term, Open-Label, Safety Study of Oral Olanzapine in Adolescents With Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Mean change from baseline to 52 week endpoint in body mass index (BMI) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean change from baseline to 52 week endpoint in BMI for patients with duration of treatment of at least 6 months [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
  • Time to event for 7%, 15%, and 25% weight gain for all patients [ Time Frame: Through 52 weeks ] [ Designated as safety issue: Yes ]
  • Mean change from baseline to 52 week endpoint in Adolescent Structured Young Mania Rating Scale [YMRS] for bipolar I disorder patients [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
  • Mean changes from baseline to 52 week endpoint in Clinical Global Impression of Improvement (CGI-I). [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
  • Mean change from baseline to 52 week endpoint in waist circumference for all patients [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
  • Mean changes from baseline to 52 week endpoint in Clinical Global Impression - Severity (CGI-S) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
  • Mean changes from baseline to 52 week endpoint in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C), for schizophrenia patients [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: October 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olanzapine/standard behavioral weight intervention Drug: Olanzapine
2.5mg to 20mg given orally, daily for 52 weeks
Other Names:
  • Zyprexa
  • LY170053
Behavioral: Standard behavioral weight intervention
One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only.
Experimental: Olanzapine/intense behavioral weight intervention Drug: Olanzapine
2.5mg to 20mg given orally, daily for 52 weeks
Other Names:
  • Zyprexa
  • LY170053
Behavioral: Intense behavioral weight intervention
Counseling and tools provided at randomization and throughout the study by appropriately trained individual regarding healthy lifestyle habits and be provided simple tools to help enable healthy eating and exercise habits. There will be two levels of rigor for the Intense Intervention: Tier 1 and Tier 2.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982020

Locations
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lauderhill, Florida, United States, 33319
United States, Michigan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bloomfield Hills, Michigan, United States, 48302
United States, Missouri
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
St Louis, Missouri, United States, 63128
United States, Washington
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bellevue, Washington, United States, 98007
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Poznan, Poland, 60-792
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Torun, Poland, 87-100
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wroclaw, Poland, 54-235
Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Caguas, Puerto Rico, 00725
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Juan, Puerto Rico, 00927
Russian Federation
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lipetsk, Russian Federation, 399313
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Moscow, Russian Federation, 115522
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Petrozavodsk, Russian Federation, 185001
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saint Petersburg, Russian Federation, 192019
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saratov, Russian Federation, 410060
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00982020     History of Changes
Other Study ID Numbers: 12117, F1D-MC-HGMX
Study First Received: September 15, 2009
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
safety
schizophrenia
bipolar I (manic or mixed)
adolescents
weight management

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on August 26, 2014