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Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine

NCT00401973 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2009-10-06

Study results available
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Summary

The goal of this study is to answer the following questions:

* Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the weight gain that is associated with olanzapine
* Whether taking amantadine, metformin or zonisamide can help patients decrease or eliminate some of the changes in body that occur with weight gain
* How weight gain associated with olanzapine can affect people
* Whether treatment with amantadine, metformin or zonisamide can help eliminate weight gain associated with olanzapine and not interfere with the positive effects of olanzapine on functioning of people with schizophrenia and other diseases

Conditions

Interventions

DRUG

olanzapine

5-20 milligrams (mg), oral, daily for 22 weeks.

DRUG

amantadine

Amantadine, 100 milligrams (mg), oral, 1 twice a day (BID). Patients who gained greater than 3 kilograms (kg) will switch to metformin. Patients who gained greater than 3 kg after switching to metformin will be switched to zonisamide.

DRUG

metformin

Metformin, 500 mg, oral, twice a day (BID) for 2 weeks titrated to 500mg three times a day (TID) thereafter. Patients who gain greater than 3 kilograms (kg) will be switched to amantadine. Patients who gained greater than 3 kg after switching to amantadine will be switched to zonisamide.

DRUG

zonisamide

Zonisamide, 100-400mg, oral, daily.

BEHAVIORAL

Wellness education

weight management

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
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States
  • Brazil
  • Israel
  • Mexico
  • Puerto Rico
  • Russia
  • South Korea

Study Locations

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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 NCT00401973 on ClinicalTrials.gov