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: December 8, 2014
Last verified: December 2014

September 15, 2009
December 8, 2014
September 2009
May 2013   (final data collection date for primary outcome measure)
Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants [ 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 Endpoint in Body Mass Index (BMI) for Participants 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 Participants [ Time Frame: Baseline up to 52 weeks ] [ Designated as safety issue: Yes ]
    Kaplan-Meier methodology used to estimate time to event. Participants who never reached the target weight gain contributed to the set of patients at risk up to the point at which they discontinued from the study and were then censored (i.e., removed from the risk set).
  • Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
    The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (symptom not present) to 60 (symptom extremely severe).
  • Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The Clinical Global Impression of Improvement (CGI-I) is used by the clinician to record the improvement of illness at the time of assessment. The score ranges from 1 (very much improved) to 7 (very much worse).
  • Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
    The CGI-S is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill.
  • Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
    The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
  • 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
    2.5 milligrams (mg) to 20 mg 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 provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits.
  • 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
203
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
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
Germany
 
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
December 2014

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