Phase 4
N=291
A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression
Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT00844857 ↗Enrolled (actual)
291
Serious AEs
5.9%
Results posted
Feb 2013
Primary outcome: Primary: Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8 — -28.43; -23.40 units on a scale — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Olanzapine Fluoxetine Combination (OFC) (Drug); Placebo (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8 |
-28.43; -23.40 | 0.003 sig |
| SECONDARY Percentage of Participants With Remission Up to Week 8 |
59.0; 43.4 | 0.035 sig |
| SECONDARY Percentage of Participants With Response Up to Week 8 |
78.2; 59.2 | 0.003 sig |
| SECONDARY Percentage of Participants in Each Improvement Category Up to Week 8 |
12.8; 22.4; 9.0; 18.4; 21.8; 18.4 | 0.007 sig |
| SECONDARY Change From Baseline in the YMRS Total Score at Week 8 |
-2.02; -1.57 | 0.527 |
| SECONDARY Change From Baseline in the Clinical Global Impression Scale - Bipolar Version (CGI-BP) Score at Week 8 |
-2.21; -1.83 | 0.030 sig |
| SECONDARY Change From Baseline in the CDRS-R Total Score Up to Week 8 |
-28.57; -23.38 | 0.002 sig |
| SECONDARY Percentage of Participants With at Least One Treatment-Emergent Incident of Akathisia Up to Week 8 |
1.3; 0.0 | 1.00 |
| SECONDARY Percentage of Participants With Treatment Emergent Suicidal Ideation or Behavior Up to Week 8 |
10.6; 15.5; 1.8; 2.4; 10.6; 15.5 | 0.309 |
| SECONDARY Percentage of Participants With at Least One Incident of Worsening of Mania Up to Week 8 |
1.2; 0.0 | 1.00 |
| SECONDARY Change From Baseline in Symptoms of Attention-Deficit/Hyperactivity Disorder Up to Week 8 |
-4.31; -3.57 | 0.545 |
| SECONDARY Change From Baseline in the Quality of Life Questionnaire for Children and Adolescents (KINDL) Parent Scale Up to Week 8 |
15.98; 10.88 | 0.066 |
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)
Eligibility Criteria
Inclusion Criteria
- Male or female inpatients or outpatients, 10-17 years of age, who have not reached their 18th birthday prior to screening. Patient must weigh at least 20 kilograms (kg) 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, Fourth Edition, Text Version (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 Children's Depression Rating Scale-Revised (CDRS-R) (entry score of greater than or equal to 40) as well as the adolescent-structured Young Mania Rating Scale (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
Data sourced from ClinicalTrials.gov (NCT00844857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.