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A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Depression

Intervention: Olanzapine Fluoxetine Combination (OFC) (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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)

Clinical Details

Official title: Study to Assess 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 I Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8

Secondary outcome:

Percentage of Participants With Remission Up to Week 8

Percentage of Participants With Response Up to Week 8

Percentage of Participants in Each Improvement Category Up to Week 8

Change From Baseline in the YMRS Total Score at Week 8

Change From Baseline in the Clinical Global Impression Scale - Bipolar Version (CGI-BP) Score at Week 8

Change From Baseline in the CDRS-R Total Score Up to Week 8

Percentage of Participants With at Least One Treatment-Emergent Incident of Akathisia Up to Week 8

Percentage of Participants With Treatment Emergent Suicidal Ideation or Behavior Up to Week 8

Percentage of Participants With at Least One Incident of Worsening of Mania Up to Week 8

Change From Baseline in Symptoms of Attention-Deficit/Hyperactivity Disorder Up to Week 8

Change From Baseline in the Quality of Life Questionnaire for Children and Adolescents (KINDL) Parent Scale Up to Week 8

Eligibility

Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

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 hours, EST), or speak with your personal physician., Lipetsk 399313, Russian Federation

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 hours, EST), or speak with your personal physician., Moscow 123367, Russian Federation

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 hours, EST), or speak with your personal physician., Saratov 410060, Russian Federation

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 hours, EST), or speak with your personal physician., Stavropol 355038, Russian Federation

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 hours, EST), or speak with your personal physician., Tver 170005, Russian Federation

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 hours, EST), or speak with your personal physician., Yaroslavl 150003, Russian Federation

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 hours, EST), or speak with your personal physician., San Diego, California 92123, United States

Additional Information

Starting date: April 2009
Last updated: January 16, 2013

Page last updated: August 23, 2015

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