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

NCT00401973 | Completed Phase 3 Results

• 2 other identifiers: 10768F1D-US-HGMM
• Study Type: interventional
• Target: 199
• Locations: 7 countries
• Sites: 15

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

Conditions

Schizophrenia; Schizoaffective Disorders

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Endpoint in Weight

  Baseline to endpoint (22 weeks)

Secondary Outcomes (10)

• 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)

Study Arms (3)

Olanzapine

EXPERIMENTAL

olanzapine plus behavioral information

Drug: olanzapine; Behavioral: Wellness education

Olanzapine + Amantadine

EXPERIMENTAL

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

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

Olanzapine + Metformin

EXPERIMENTAL

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

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

Interventions

olanzapine DRUG

5-20 milligrams (mg), oral, daily for 22 weeks.

Also known as: LY170053, Zyprexa

Olanzapine; Olanzapine + Amantadine; Olanzapine + Metformin

amantadine DRUG

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.

Olanzapine + Amantadine; Olanzapine + Metformin

metformin DRUG

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.

Olanzapine + Amantadine; Olanzapine + Metformin

zonisamide DRUG

Zonisamide, 100-400mg, oral, daily.

Olanzapine + Amantadine; Olanzapine + Metformin

Wellness education BEHAVIORAL

weight management

Olanzapine; Olanzapine + Amantadine; Olanzapine + Metformin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (15)

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, 91950, United States

Location

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, 44708, United States

Location

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, 37614, United States

Location

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, 38105, United States

Location

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, 75115, United States

Location

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, 21020-130, Brazil

Location

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, 40301500, Brazil

Location

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, 70350, Israel

Location

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, 14050, Mexico

Location

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.

Bayamón, 00961, Puerto Rico

Location

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, 00717, Puerto Rico

Location

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, 00907, Puerto Rico

Location

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

Location

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, 117603, Russia

Location

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, 143-711, South Korea

Location

Related Publications (2)

• Hoffmann VP, Case M, Jacobson JG. Assessment of treatment algorithms including amantadine, metformin, and zonisamide for the prevention of weight gain with olanzapine: a randomized controlled open-label study. J Clin Psychiatry. 2012 Feb;73(2):216-23. doi: 10.4088/JCP.09m05580. Epub 2011 May 17.

  PMID: 21672497 DERIVED

• Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72. doi: 10.1186/1471-244X-10-72.

  PMID: 20840778 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Olanzapine; Amantadine; Metformin; Zonisamide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Biguanides; Guanidines; Amidines; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 22, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 6, 2009
• Results First Posted: September 30, 2009

Record last verified: 2009-09

Locations

BR (2); PR (4); KR (1); IL (1); US (5); ME (1); RU (1)