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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00401973
First received: November 17, 2006
Last updated: September 30, 2009
Last verified: September 2009
  Purpose

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

Condition Intervention Phase
Schizophrenia
Schizoaffective Disorders
Drug: olanzapine
Drug: amantadine
Drug: metformin
Drug: zonisamide
Behavioral: Wellness education
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change From Baseline to Endpoint in Weight [ Time Frame: Baseline to endpoint (22 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean Change From Baseline to Endpoint in Fasting Triglycerides [ Time Frame: Baseline to endpoint (22 weeks) ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Endpoint in Fasting Total Cholesterol [ Time Frame: Baseline to endpoint (22 weeks) ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol [ Time Frame: Baseline to endpoint (22 weeks) ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Baseline to endpoint (22 weeks) ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Endpoint in Fasting Glucose [ Time Frame: Baseline to endpoint (22 weeks) ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Endpoint in Hemoglobin A1c [ Time Frame: Baseline to endpoint (22 weeks) ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score [ Time Frame: Baseline to endpoint (22 weeks) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline to endpoint (22 weeks) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S) [ Time Frame: Baseline to endpoint (22 weeks) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 199
Study Start Date: November 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olanzapine
olanzapine plus behavioral information
Drug: olanzapine
5-20 milligrams (mg), oral, daily for 22 weeks.
Other Names:
  • LY170053
  • Zyprexa
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:
  • LY170053
  • Zyprexa
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.
Behavioral: Wellness education
weight management
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:
  • LY170053
  • Zyprexa
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.
Behavioral: Wellness education
weight management

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401973

Locations
United States, California
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, United States, 91950
United States, Ohio
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, 44708
United States, Tennessee
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, 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
United States, Texas
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, 75115
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, 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
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, Israel, 70350
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, Korea, Republic of, 143-711
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, Mexico, 14050
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, 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
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
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, Russian Federation, 117603
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00401973     History of Changes
Other Study ID Numbers: 10768, F1D-US-HGMM
Study First Received: November 17, 2006
Results First Received: August 27, 2009
Last Updated: September 30, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Weight Gain
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Amantadine
Zonisamide
Olanzapine
Metformin
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypoglycemic Agents
Antioxidants
Protective Agents

ClinicalTrials.gov processed this record on April 15, 2014