Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine
Condition: Schizophrenia; Schizoaffective Disorders
MeSH terms: Weight Gain; Schizophrenia; Psychotic Disorders
Intervention: olanzapine; amantadine; metformin; zonisamide; Wellness education
Intervention description: 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
Intervention MeSH terms: Metformin; Amantadine; Zonisamide; Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  You must have been diagnosed with schizophrenia or schizoaffective disorder

          -  You must be able to visit the doctor's office once every two weeks for three months,
             then once every four weeks for the next three months with a possible bi-weekly visit
             during the fifth month

          -  If you are currently taking a medication for schizophrenia or schizoaffective
             disorder, you have been taking it for at least 30 days without any changes

          -  If you are a female, you must have a negative pregnancy test and be using an effective
             method of contraception

        Exclusion Criteria:

          -  You have a diagnosis of bipolar I disorder, diabetes, very high triglyceride level
             (fasting triglycerides greater than or equal to 500 mg/dL), recent heart attack,
             stroke, uncontrolled seizures, serious infection, unstable heart disease (such as
             ischemic heart disease or congestive heart failure), an uncorrected narrow angle
             glaucoma or human immunodeficiency virus (HIV)

          -  You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine
             systems, or blood

          -  You have a diagnosis of an eating disorder

          -  You have a history of Parkinson's Disease or any related disorders

          -  You are allergic to sulfa drugs or any of the medications involved in this study