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

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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)

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

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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