NCT00401973

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

The Assessment of the Safety, Efficacy, and Practicality of an Algorithm Including Amantadine, Metformin and Zonisamide for the Prevention of Olanzapine-Associated Weight Gain in Outpatients With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Schizophrenia
• Schizoaffective Disorders

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2006-11-22
• Last updated: 2009-10-06
• Results posted: 2009-09-30

Locations

15 sites across 7 countries: United States, Brazil, Israel, Mexico, Puerto Rico, Russia, South Korea