NCT00844857

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)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2009

Typical duration for phase_4

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 18, 2013

Completed
Last Updated

February 18, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

February 13, 2009

Results QC Date

January 16, 2013

Last Update Submit

January 16, 2013

Conditions

Bipolar Depression

Keywords

Bipolar I Depression

Outcome Measures

Primary Outcomes (1)

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

    CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) mean was adjusted for baseline, country, treatment, visit, and treatment times (\*) visit interaction.

    Baseline, Week 8

Secondary Outcomes (11)

  • Percentage of Participants With Remission Up to Week 8

    Baseline up to Week 8

  • Percentage of Participants With Response Up to Week 8

    Baseline up to Week 8

  • Percentage of Participants in Each Improvement Category Up to Week 8

    Baseline up to Week 8

  • Change From Baseline in the YMRS Total Score at Week 8

    Baseline, Week 8

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

    Baseline, Week 8

  • +6 more secondary outcomes

Other Outcomes (8)

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

    Baseline, Week 8

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

    Baseline, Week 8

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

    Baseline, Week 8

  • +5 more other outcomes

Study Arms (2)

Olanzapine/Fluoxetine Combination

EXPERIMENTAL
Drug: Olanzapine Fluoxetine Combination (OFC)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Olanzapine Fluoxetine Combination (OFC)DRUG

OFC doses are capsules of 3 milligrams (mg) olanzapine and 25 mg fluoxetine (3/25), 6/25, 12/25, 6/50, or 12/50 mg to be taken orally once daily in the evening for 8 weeks.

Also known as: LY900000, Symbyax
Olanzapine/Fluoxetine Combination
PlaceboDRUG

Orally, once daily in the evening for 8 weeks.

Placebo

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

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

Location

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, Russia

Location

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, Russia

Location

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, Russia

Location

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, Russia

Location

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, Russia

Location

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, Russia

Location

Related Publications (2)

  • 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.

    PMID: 28706563DERIVED

  • 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.

    PMID: 25721187DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

olanzapine-fluoxetine combination

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 16, 2009

Study Start

April 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 18, 2013

Results First Posted

February 18, 2013

Record last verified: 2013-01

Locations

RU(6)US(1)