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A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression
This study is currently recruiting participants.
Verified January 2012 by Eli Lilly and Company

First Received on February 13, 2009.   Last Updated on January 20, 2012   History of Changes
Sponsor: Eli Lilly and Company
Information provided by (Responsible Party): Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00844857
  Purpose

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)

Condition Intervention Phase
Bipolar Depression
Drug: Olanzapine Fluoxetine Combination
Drug: Placebo
Phase IV

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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Children's Depression Rating Scale Revised (CDRS-R) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: April 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olanzapine/Fluoxetine Combination 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
Other Names:
  • LY900000
  • Symbyax
Placebo Comparator: Placebo Drug: Placebo
PO daily in the evening for 8 weeks

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844857

Contacts
Contact: There may be multiple sites in the clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
United States, California
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. Recruiting
San Diego, California, United States, 92123
Contact: Eli Lilly            
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. Recruiting
Wildomar, California, United States, 92595
Contact: Eli Lilly            
United States, Colorado
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. Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Florida
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. Recruiting
Lauderhill, Florida, United States, 33319
Contact: Eli Lilly            
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. Recruiting
Miami, Florida, United States, 33155
Contact: Eli Lilly            
United States, Illinois
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. Recruiting
Naperville, Illinois, United States, 60563
Contact: Eli Lilly            
United States, New York
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. Recruiting
Staten Island, New York, United States, 10312
Contact: Eli Lilly            
United States, Texas
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. Recruiting
San Antonio, Texas, United States, 78258
Contact: Eli Lilly            
United States, Utah
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. Active, not recruiting
Salt Lake City, Utah, United States, 84132
United States, Washington
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. Active, not recruiting
Bellevue, Washington, United States, 98007
United States, Wisconsin
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. Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Eli Lilly            
Mexico
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. Active, not recruiting
Leon, Mexico, 37000
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. Recruiting
Monterrey, Mexico, 64000
Contact: Eli Lilly            
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. Recruiting
Lipetsk, Russian Federation, 399313
Contact: Eli Lilly            
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. Recruiting
Moscow, Russian Federation, 123367
Contact: Eli Lilly            
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. Recruiting
Saratov, Russian Federation, 410060
Contact: Eli Lilly            
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. Recruiting
Stavropol, Russian Federation, 355038
Contact: Eli Lilly            
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. Recruiting
Tver, Russian Federation, 170005
Contact: Eli Lilly            
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. Recruiting
Yaroslavl, Russian Federation, 150003
Contact: Eli Lilly            
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00844857     History of Changes
Other Study ID Numbers: 12116, H6P-MC-HDAX
Study First Received: February 13, 2009
Last Updated: January 20, 2012
Health Authority: United States: Food and Drug Administration;   Russia: Ethics Committee;   Mexico: Ministry of Health;   Turkey: Ministry of Health

Keywords provided by Eli Lilly and Company:
Bipolar I Depression

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Fluoxetine
Olanzapine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012