CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 203 enrolled
Drug / intervention
Olanzapine +2 moredrug
Likely dose
Olanzapine 2.5 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00982020
NCT00982020Phase 4Completed
CompareCT.gov

A Long-Term, Open-Label, Safety Study of Oral Olanzapine in Adolescents With Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia

Eli Lilly and Company·interventional·Posted Sep 22, 2009·Updated Dec 17, 2014

In Brief

A Phase 4 clinical trial evaluating Olanzapine, Standard behavioral weight intervention, and 1 other intervention for Bipolar I Disorder and Schizophrenia. Completed, enrolled 203 participants across 14 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder, Schizophrenia
CountriesPoland, Puerto Rico, Russia, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2009
Enrollment StartSep 1, 2009
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 16.8 years ago

Interventions

Olanzapinedrug

2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks

Standard behavioral weight interventionbehavioral

One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only.

Intense behavioral weight interventionbehavioral

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.