At a glance
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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
In Brief
A Phase 3 clinical trial evaluating olanzapine, amantadine, and 3 other interventions for Schizophrenia and Schizoaffective Disorders. Completed, enrolled 199 participants across 15 sites in 7 countries.
Detailed 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
Study Details
Timeline
Interventions
5-20 milligrams (mg), oral, daily for 22 weeks.
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.
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.
Zonisamide, 100-400mg, oral, daily.
weight management