CompletedNCT00844857
A Study for Assessing Treatment of Patients Ages 10-17 With Depression in bipolarity
Researchers compared Olanzapine Fluoxetine Combination (OFC) and placebo, tracking side effects to assess safety in people with bipolarity type I.
Medication studyAges 10–17Russia + United States
Understand this study
What did researchers investigate?
Researchers compared Olanzapine Fluoxetine Combination (OFC) and placebo, tracking side effects to assess safety in people with bipolarity type I.
Who was this study for?
This study was for people with bipolarity. Listed age limits: 10 years to 17 years. Other eligibility criteria applied.
- Listed locations
- San Diego and 6 more locationsSee all locations and recruitment
- Study phase
- Phase 4Usually happens after approval, to monitor real-world use, safety, and longer-term outcomes.
Study information
Study start dateApril 2009
- Recruitment status
- Completed
- Enrollment listed in the registry
- 291
- Sponsor
- Eli Lilly and Company
- Sponsor type
- Other organization
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 4Usually happens after approval, to monitor real-world use, safety, and longer-term outcomes.
- Locations
- United States, Russia
- Age range
- From 10 Years to 17 Years
- Official registry ID
- NCT00844857
- Official title
Show the full 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
Recruitment & locations
CompletedSan Diego, United States · Lipetsk, Russia · Moscow, Russia
5 more locations
- Saratov, Russia
- Stavropol, Russia
- Tver', Russia
- Yaroslavl, Russia
- Russia
Questions about this study
What did researchers investigate?
Researchers compared Olanzapine Fluoxetine Combination (OFC) and placebo, tracking side effects to assess safety in people with bipolarity type I.
Who is behind this study?
The study sponsor is Eli Lilly and Company.
Did this study involve medication?
Yes. The study involved medication, including Olanzapine Fluoxetine Combination (OFC) and Placebo.
Who was this study for?
This study was for people with bipolarity. Listed age limits: 10 years to 17 years. Other eligibility criteria applied.
Want to find a study that may fit you better?
Answer a few simple questions to explore HopeStage studies by condition, country, and situation.
Find a study that may fit me