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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

September 15, 2009
May 17, 2013
October 2009
May 2013   (final data collection date for primary outcome measure)
Mean change from baseline to 52 week endpoint in body mass index (BMI) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
Mean change from baseline to 52 week endpoint in body mass index (BMI) for patients with duration of treatment of at least 6 months [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00982020 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Mean change from baseline to 52 week endpoint in BMI for all patients [ 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 ]
Not Provided
Not Provided
 
Study in Adolescents With Schizophrenia or Bipolar Disorder
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bipolar I Disorder
  • Schizophrenia
  • 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.
  • 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.
  • Experimental: Olanzapine/standard behavioral weight intervention
    Interventions:
    • Drug: Olanzapine
    • Behavioral: Standard behavioral weight intervention
  • Experimental: Olanzapine/intense behavioral weight intervention
    Interventions:
    • Drug: Olanzapine
    • Behavioral: Intense behavioral weight intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
13 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Poland,   Puerto Rico,   Russian Federation
 
NCT00982020
12117, F1D-MC-HGMX
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP