A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression
Tracking Information| Start Date ICMJE | April 2009 |
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| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE
(submitted: February 13, 2009) | Children's Depression Rating Scale Revised (CDRS-R) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] |
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| Original Primary Outcome Measures ICMJE | Same as current |
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| Change History | Complete list of historical versions of study NCT00844857 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE
(submitted: February 13, 2009) | - Rate of response and time to response as determined by greater than or equal to 50% reduction from Baseline on CDRS-R total score AND a score of less than or equal to 2 on Young Mania Rating Scale (YMRS) item 1 [Elevated Mood] score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Rate of remission and time to remission as determined by a CDRS-R total score of 28 or less, YMRS total score of 8 or less, AND Clinical Global Impression Scale-Bipolar Version (CGI-BP) total score of less than or equal to 3 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Level of improvement of bipolar disorder as determined by percentage reduction from Baseline on CDRS-R total score and YMRS item 1 [Elevated Mood] score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Mean change in Young Mania Rating Scale (YMRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Mean change in Clinical Global Impression Scale - Bipolar Version (CGI-BP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Last Observation Carried Forward (LOCF) on CDRSR total score and individual items [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Comparing incidence of extrapyramidal symptoms (EPS) using Barnes Akathisia Rating Scale, Abnormal Involuntary Movements Scale (AIMS), and Simpson-Angus Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Comparing the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the treatment period using Columbia Suicide-Severity Rating Scale (CSSRS). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Evaluating the difference in the incidence of worsening of manic symptoms as measured by YMRS total score and CGI-BP Severity of Mania score. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Assess the treatment effects associated with comorbidity of Attention-Deficit/Hyperactivity Disorder (ADHD) as determined by Attention Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-PI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Assess the health-related quality of life using the Quality of Life Questionnaire for Children and Adolescents (KINDL®; both the patient and parent questionnaires) and assess hospitalization rates using the Lilly Healthcare Services Information Module [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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| Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive Information| Brief Title ICMJE | A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression |
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| Official Title ICMJE | Study to Access the Efficacy and Safety of Olanzapine and Fluoxetine Combination Versus Placebo in Patients Ages 10-17 in the Treatment of Major Depressive Episodes Associated With Bipolar Disorder |
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| Brief Summary | The main goal of this study is to help answer the following research question(s) and not to treat the child's illness. - Can this study drug make children with bipolar depression feel better?
- Does this study drug work better than a placebo (sugar pill)?
- Does this study drug cause side effects in children who take it?
- Is this drug safe to use in children? (The study drug is a mixture of olanzapine and fluoxetine)
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| Detailed Description | |
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| Study Phase | Phase IV |
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| Study Type ICMJE | Interventional |
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| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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| Condition ICMJE | Bipolar Depression |
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| Intervention ICMJE | - Drug: Olanzapine Fluoxetine Combination
(Olanzapine/Fluoxetine doses are capsules of 3/25, 6/25, 12/25, 6/50, or 12/50mg) to be taken PO once daily in the evening for 8 weeks - Drug: Placebo
PO daily in the evening for 8 weeks
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| Study Arms / Comparison Groups | |
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Recruitment Information| Estimated Enrollment ICMJE | 300 |
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| Estimated Completion Date | November 2011 |
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| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) |
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| Eligibility Criteria ICMJE | Inclusion Criteria: - Male or female inpatients or outpatients, 10-17 yrs of age, who have not reached their 18th birthday prior to screening. Patient must weigh at least 20kg at screening.
- Must meet diagnostic criteria for current major depressive episode of Bipolar I Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, DSM-IV-TR, and confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL)
- Patients entering the study will also be scored by the CDRS R (entry score of greater than or equal to 40) as well as the adolescent-structured YMRS (entry score of less than or equal to 15 with YMRS Item 1 [elevated mood] score less than equal to 2).
Exclusion Criteria: - Patients will be excluded if they are, in the opinion of the investigator, actively suicidal
- Have an acute, serious or unstable medical condition
- Have clinically significant laboratory abnormalities
- Have had one or more seizures of unclear etiology
- Have a current or lifetime diagnosis of any of the following according to DSM-IV criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Delirium of any type, Amnestic Disorder, any Substance-Induced Disorder, or any Psychotic Disorder due to a General Medical Condition, unless there is substantive reason to believe patient was misdiagnosed
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| Gender | Both |
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| Ages | 10 Years to 17 Years |
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| Accepts Healthy Volunteers | No |
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| Contacts ICMJE | | Contact: There may be multiple sites in the clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | | |
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| Location Countries ICMJE | United States, Mexico, Puerto Rico, Russian Federation, Turkey |
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Administrative Information| NCT ID ICMJE | NCT00844857 |
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| Responsible Party | Chief Medical Officer, Eli Lilly |
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| Study ID Numbers ICMJE | 12116, H6P-MC-HDAX |
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| Study Sponsor ICMJE | Eli Lilly and Company |
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| Collaborators ICMJE | |
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| Investigators ICMJE | | 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 | |
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| Information Provided By | Eli Lilly and Company |
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