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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401973
• Other study ID #: 10768
• Secondary ID: F1D-US-HGMM
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2006
• Last updated: September 30, 2009
• Start date: November 2006
• Est. completion date: September 2008

Study information

• Verified date: September 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorders
• Schizophrenia
• Weight Gain

Intervention

Drug:
• olanzapine
5-20 milligrams (mg), oral, daily for 22 weeks.
• amantadine
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
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
Zonisamide, 100-400mg, oral, daily.

Behavioral:
• Wellness education
weight management

Locations

Country	Name	City	State
Brazil	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.	Rio De Janeiro
Brazil	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.	Salvador
Israel	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.	Beer Yaacov
Korea, Republic of	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.	Seoul
Mexico	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.	Mexico City
Puerto Rico	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.	Bayamon
Puerto Rico	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.	Ponce
Puerto Rico	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.	San Juan
Puerto Rico	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.	San Juan
Russian Federation	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.	Moscow
United States	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.	Canton	Ohio
United States	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.	Desoto	Texas
United States	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.	Johnson City	Tennessee
United States	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.	Memphis	Tennessee
United States	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.	National City	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Brazil,  Israel,  Korea, Republic of,  Mexico,  Puerto Rico,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Endpoint in Weight		Baseline to endpoint (22 weeks)	Yes
Secondary	Mean Change From Baseline to Endpoint in Fasting Triglycerides		Baseline to endpoint (22 weeks)	Yes
Secondary	Mean Change From Baseline to Endpoint in Fasting Total Cholesterol		Baseline to endpoint (22 weeks)	Yes
Secondary	Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol		Baseline to endpoint (22 weeks)	Yes
Secondary	Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol		Baseline to endpoint (22 weeks)	Yes
Secondary	Mean Change From Baseline to Endpoint in Fasting Glucose		Baseline to endpoint (22 weeks)	Yes
Secondary	Mean Change From Baseline to Endpoint in Hemoglobin A1c		Baseline to endpoint (22 weeks)	Yes
Secondary	Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score		Baseline to endpoint (22 weeks)	No
Secondary	Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score		Baseline to endpoint (22 weeks)	No
Secondary	Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)		Baseline to endpoint (22 weeks)	No
Secondary	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)	No

External Links

•   Lilly Clinical Trial Registry