Back to resultsOlanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Olanzapine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
Inclusion Criteria: Male or female patients, 13 to 17 years of age who must not yet have reached their 18th birthday prior to Visit 1, when informed consent is obtained. Patients must have a diagnosis of bipolar I disorder and currently display an acute mania or mixed episode. Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent. Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Exclusion Criteria: Female patients who are either pregnant or nursing. Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder. Patient with acute or unstable medical conditions, such that intensive care unit hospitalization for the disease is anticipated within 6 months. Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment. Patients who have been judged clinically to be serious suicidal risks.
Sites / Locations
- 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 hrs, EST), or speak with your personal physician.
Outcomes
Primary Outcome Measures
Assess the efficacy of a flexible dose of olanzapine compared with placebo in the treatment of mania in bipolar I disorder (manic or mixed episode associated with bipolar I disorder, with or without psychotic features) in adolescents
Secondary Outcome Measures
Assess additional efficacy as measured by Y-MRS,CGI-BP Severity of Illness, CGI-BP Severity of Illness (CGI-BP Severity of Mania, CGI-BP Severity of Depression, and CGI-BP Severity Overall)
Assess additional efficacy as measured by Children's Depression Rating Scale-Revised (CDRS- R);Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IVPI) and Overt Aggression Scale (OAS).
Assess the safety of olanzapine and quality of life associated with olanzapine compared with placebo.
Compare the frequency of response of up to 3-weeks, double-blind treatment and up to an additional 26 weeks of open-label olanzapine treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00050206
Brief Title
Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder
Official Title
Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of mania in bipolar disorder in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
130 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Assess the efficacy of a flexible dose of olanzapine compared with placebo in the treatment of mania in bipolar I disorder (manic or mixed episode associated with bipolar I disorder, with or without psychotic features) in adolescents
Secondary Outcome Measure Information:
Title
Assess additional efficacy as measured by Y-MRS,CGI-BP Severity of Illness, CGI-BP Severity of Illness (CGI-BP Severity of Mania, CGI-BP Severity of Depression, and CGI-BP Severity Overall)
Title
Assess additional efficacy as measured by Children's Depression Rating Scale-Revised (CDRS- R);Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IVPI) and Overt Aggression Scale (OAS).
Title
Assess the safety of olanzapine and quality of life associated with olanzapine compared with placebo.
Title
Compare the frequency of response of up to 3-weeks, double-blind treatment and up to an additional 26 weeks of open-label olanzapine treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients, 13 to 17 years of age who must not yet have reached their 18th birthday prior to Visit 1, when informed consent is obtained.
Patients must have a diagnosis of bipolar I disorder and currently display an acute mania or mixed episode.
Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent.
Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.
Exclusion Criteria:
Female patients who are either pregnant or nursing.
Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder.
Patient with acute or unstable medical conditions, such that intensive care unit hospitalization for the disease is anticipated within 6 months.
Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
Patients who have been judged clinically to be serious suicidal risks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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 hrs, EST), or speak with your personal physician.
City
Indianapolis
State/Province
Indiana
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28922591
Citation
Xiao L, Ganocy SJ, Findling RL, Chang K, DelBello MP, Kane JM, Tohen M, Xiang YT, Correll CU. Baseline Characteristics and Early Response at Week 1 Predict Treatment Outcome in Adolescents With Bipolar Manic or Mixed Episode Treated With Olanzapine: Results From a 3-Week, Randomized, Placebo-Controlled Trial. J Clin Psychiatry. 2017 Nov/Dec;78(9):e1158-e1166. doi: 10.4088/JCP.16m10923.
Results Reference
derived
PubMed Identifier
19210948
Citation
Kryzhanovskaya LA, Robertson-Plouch CK, Xu W, Carlson JL, Merida KM, Dittmann RW. The safety of olanzapine in adolescents with schizophrenia or bipolar I disorder: a pooled analysis of 4 clinical trials. J Clin Psychiatry. 2009 Feb;70(2):247-58. doi: 10.4088/jcp.08m03538. Epub 2009 Feb 10. Erratum In: J Clin Psychiatry. 2009 Dec;70(12):1729.
Results Reference
derived
PubMed Identifier
17898346
Citation
Tohen M, Kryzhanovskaya L, Carlson G, Delbello M, Wozniak J, Kowatch R, Wagner K, Findling R, Lin D, Robertson-Plouch C, Xu W, Dittmann RW, Biederman J. Olanzapine versus placebo in the treatment of adolescents with bipolar mania. Am J Psychiatry. 2007 Oct;164(10):1547-56. doi: 10.1176/appi.ajp.2007.06111932.
Results Reference
derived
Learn more about this trial
Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder
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