Trials / Completed
CompletedNCT00982020
Study in Adolescents With Schizophrenia or Bipolar Disorder
A Long-Term, Open-Label, Safety Study of Oral Olanzapine in Adolescents With Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 203 (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 13 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years, with bipolar I disorder (manic or mixed episodes) or schizophrenia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olanzapine | 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks |
| BEHAVIORAL | Standard behavioral weight intervention | One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only. |
| BEHAVIORAL | Intense behavioral weight intervention | Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits. |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2009-09-22
- Last updated
- 2014-12-17
- Results posted
- 2014-12-17
Locations
14 sites across 4 countries: United States, Poland, Puerto Rico, Russia
Source: ClinicalTrials.gov record NCT00982020. Inclusion in this directory is not an endorsement.