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

Phase 3

Completed

Conditions: Schizophrenia
Schizoaffective Disorders

Interventions: Drug: olanzapine
Behavioral: Wellness education
Drug: amantadine
Drug: metformin
Drug: zonisamide

Registration Number: NCT00401973

Lead Sponsor: Eli Lilly and Company

Brief 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 199

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olanzapine	Wellness education	olanzapine plus behavioral information
Olanzapine + Amantadine	Wellness education	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
Olanzapine + Metformin	Wellness education	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information
Olanzapine + Amantadine	olanzapine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
Olanzapine	olanzapine	olanzapine plus behavioral information
Olanzapine + Amantadine	amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
Olanzapine + Amantadine	zonisamide	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
Olanzapine + Amantadine	metformin	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
Olanzapine + Metformin	olanzapine	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information
Olanzapine + Metformin	amantadine	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information
Olanzapine + Metformin	metformin	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information
Olanzapine + Metformin	zonisamide	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Endpoint in Weight	Baseline to endpoint (22 weeks)

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline to Endpoint in Fasting Triglycerides	Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting Total Cholesterol	Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol	Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol	Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting Glucose	Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Hemoglobin A1c	Baseline to endpoint (22 weeks)
Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score	Baseline to endpoint (22 weeks)	The BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Each item is rated on a scale from 1 (symptom not present) to 7 (symptom extremely severe). The BPRS total score ranges from 18 to 126.
Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Baseline to endpoint (22 weeks)	The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)	Baseline to endpoint (22 weeks)	Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Correlations Between Weight Changes and Changes in Eating Inventory (EI) and Food Craving Inventory (FCI) at 2 Weeks and 22 Weeks	Baseline to endpoint (22 weeks)	To understand the drivers of weight gain as indicated by the correlation between weight changes and changes in the Eating Inventory (EI) and Food Craving Inventory (FCI). The EI is a 51-item inventory that measures dietary restraint, disinhibition, and perceived hunger. The FCI is a 28-item instrument measuring the frequency over the past month of general cravings and cravings for specific types of foods, namely: high fats, sweets, carbohydrates/starches, and fast-food fats. Correlations were computed on the combined treatment groups.

Trial Locations

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Moscow, Russian Federation