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

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 4

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:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Fluoxetine Fluoxetine hydrochloride Olanzapine

U.S. FDA Resources

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
Study Completion Date:	February 2012
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

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.
San Diego, California, United States, 92123
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.
Lipetsk, Russian Federation, 399313
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, Russian Federation, 123367
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, Russian Federation, 410060
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, Russian Federation, 355038
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, Russian Federation, 170005
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, Russian Federation, 150003

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:	March 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 May 23, 2012