MedTrace Logo

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

NCT00844857 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2013-02-18

Study results available
· View outcomes & findings →

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)

Conditions

Interventions

DRUG

Olanzapine Fluoxetine Combination (OFC)

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.

DRUG

Placebo

Orally, once daily in the evening for 8 weeks.

Sponsors & Collaborators

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00844857 on ClinicalTrials.gov