Clinical trial NCT00844857: A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Depression
Keywords: Bipolar I Depression
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2009-02-16
Enrollment: 291
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Percentage of Participants With Remission Up to Week 8
timeFrame: Baseline up to Week 8
measure: Percentage of Participants With Response Up to Week 8
timeFrame: Baseline up to Week 8
measure: Percentage of Participants in Each Improvement Category Up to Week 8
timeFrame: Baseline up to Week 8
measure: Change From Baseline in the YMRS Total Score at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in the Clinical Global Impression Scale - Bipolar Version (CGI-BP) Score at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in the CDRS-R Total Score Up to Week 8
timeFrame: Baseline, Week 8
measure: Percentage of Participants With at Least One Treatment-Emergent Incident of Akathisia Up to Week 8
timeFrame: Baseline up to Week 8
measure: Percentage of Participants With Treatment Emergent Suicidal Ideation or Behavior Up to Week 8
timeFrame: Baseline up to Week 8
measure: Percentage of Participants With at Least One Incident of Worsening of Mania Up to Week 8
timeFrame: Baseline up to Week 8
measure: Change From Baseline in Symptoms of Attention-Deficit/Hyperactivity Disorder Up to Week 8
timeFrame: Baseline up to Week 8
measure: Change From Baseline in the Quality of Life Questionnaire for Children and Adolescents (KINDL) Parent Scale Up to Week 8
timeFrame: Baseline, Week 8
Other outcomes:
measure: Percentage of Participants With at Least One Treatment-Emergent Incident of Parkinsonism Up to Week 8
timeFrame: Baseline, Week 8
measure: Percentage of Participants With at Least One Treatment-Emergent Incident of Dyskinesia Up to Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in the Quality of Life Questionnaire for Children and Adolescents (KINDL) Kid and Kiddo Combined Scale Up to Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Weight Up to Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Fasting Metabolic Parameters Up to Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Alanine Aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) Up to Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Prolactin Up to Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Electrocardiogram (ECG) QTcF Interval Up to Week 8
timeFrame: Baseline, Week 8
Locations:
city: San Diego
country: United States
facility: 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.
state: California
city: Lipetsk
country: Russian Federation
facility: 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.
city: Moscow
country: Russian Federation
facility: 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.
city: Saratov
country: Russian Federation
facility: 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.
city: Stavropol
country: Russian Federation
facility: 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.
city: Tver
country: Russian Federation
facility: 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.
city: Yaroslavl
country: Russian Federation
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Walker DJ, DelBello MP, Landry J, D'Souza DN, Detke HC. Quality of life in children and adolescents with bipolar I depression treated with olanzapine/fluoxetine combination. Child Adolesc Psychiatry Ment Health. 2017 Jul 12;11:34. doi: 10.1186/s13034-017-0170-7. eCollection 2017.
citation: Detke HC, DelBello MP, Landry J, Usher RW. Olanzapine/Fluoxetine combination in children and adolescents with bipolar I depression: a randomized, double-blind, placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):217-24. doi: 10.1016/j.jaac.2014.12.012. Epub 2014 Dec 29.