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Study in Adolescents With Schizophrenia or Bipolar Disorder

NCT00982020 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2014-12-17

Study results available
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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

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.

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
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States
  • Poland
  • Puerto Rico
  • 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 NCT00982020 on ClinicalTrials.gov