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

September 30, 2009 updated by: Eli Lilly and Company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 21020-130
        • 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, Brazil, 40301500
        • 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.
  • Israel
      • Beer Yaacov, Israel, 70350
        • 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.
  • Korea, Republic of
      • Seoul, Korea, Republic of, 143-711
        • 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
      • Mexico City, Mexico, 14050
        • 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.
  • Puerto Rico
      • Bayamon, Puerto Rico, 00961
        • 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, 00717
        • 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, 00907
        • 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.
  • Russian Federation
      • Moscow, Russian Federation, 117603
        • 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.
  • United States
    • California
      • National City, California, United States, 91950
        • 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.
    • Ohio
      • Canton, Ohio, United States, 44708
        • 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.
    • Tennessee
      • Johnson City, Tennessee, United States, 37614
        • 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, 38105
        • 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.
    • Texas
      • Desoto, Texas, United States, 75115
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olanzapine
olanzapine plus behavioral information
Drug: olanzapine
5-20 milligrams (mg), oral, daily for 22 weeks.
Other Names:
  • Zyprexa
  • LY170053
Behavioral: Wellness education
weight management
Experimental: Olanzapine + Amantadine
Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
Drug: olanzapine
5-20 milligrams (mg), oral, daily for 22 weeks.
Other Names:
  • Zyprexa
  • LY170053
Behavioral: Wellness education
weight management
Drug: 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.
Drug: 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.
Drug: zonisamide
Zonisamide, 100-400mg, oral, daily.
Experimental: Olanzapine + Metformin
Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information
Drug: olanzapine
5-20 milligrams (mg), oral, daily for 22 weeks.
Other Names:
  • Zyprexa
  • LY170053
Behavioral: Wellness education
weight management
Drug: 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.
Drug: 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.
Drug: zonisamide
Zonisamide, 100-400mg, oral, daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline to Endpoint in Weight
Time Frame: Baseline to endpoint (22 weeks)
Baseline to endpoint (22 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline to Endpoint in Fasting Triglycerides
Time Frame: Baseline to endpoint (22 weeks)
Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting Total Cholesterol
Time Frame: Baseline to endpoint (22 weeks)
Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol
Time Frame: Baseline to endpoint (22 weeks)
Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol
Time Frame: Baseline to endpoint (22 weeks)
Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting Glucose
Time Frame: Baseline to endpoint (22 weeks)
Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Hemoglobin A1c
Time Frame: Baseline to endpoint (22 weeks)
Baseline to endpoint (22 weeks)
Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score
Time Frame: 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.
Baseline to endpoint (22 weeks)
Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time Frame: 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).
Baseline to endpoint (22 weeks)
Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)
Time Frame: 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).
Baseline to endpoint (22 weeks)
Correlations Between Weight Changes and Changes in Eating Inventory (EI) and Food Craving Inventory (FCI) at 2 Weeks and 22 Weeks
Time Frame: 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.
Baseline to endpoint (22 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

November 17, 2006

First Submitted That Met QC Criteria

November 17, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

October 6, 2009

Last Update Submitted That Met QC Criteria

September 30, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10768 (Registry Identifier: Panama ID UMCG)
  • F1D-US-HGMM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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