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

Lilly

Status and phase: Completed; Phase 3

Conditions: Schizoaffective Disorders; Schizophrenia

Treatments: Drug: metformin; Behavioral: Wellness education; Drug: zonisamide; Drug: olanzapine; Drug: amantadine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401973

10768

F1D-US-HGMM

Details and patient eligibility

About

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

Enrollment: 199 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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199 participants in 3 patient groups

Olanzapine

Experimental group

Description:

olanzapine plus behavioral information

Treatment:

Drug: olanzapine

Behavioral: Wellness education

Olanzapine + Amantadine

Experimental group

Description:

Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information

Treatment:

Drug: metformin

Drug: zonisamide

Drug: olanzapine

Drug: amantadine

Behavioral: Wellness education

Olanzapine + Metformin

Experimental group

Description:

Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information

Treatment:

Drug: metformin

Drug: zonisamide

Drug: olanzapine

Drug: amantadine

Behavioral: Wellness education