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

Overview[ - collapse ][ - ]

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
ConditionSchizophrenia
Schizoaffective Disorders
InterventionDrug: olanzapine
Drug: amantadine
Drug: metformin
Drug: zonisamide
Behavioral: Wellness education
PhasePhase 3
SponsorEli Lilly and Company
Responsible PartyEli Lilly and Company
ClinicalTrials.gov IdentifierNCT00401973
First ReceivedNovember 17, 2006
Last UpdatedSeptember 30, 2009
Last verifiedSeptember 2009

Tracking Information[ + expand ][ + ]

First Received DateNovember 17, 2006
Last Updated DateSeptember 30, 2009
Start DateNovember 2006
Estimated Primary Completion DateSeptember 2008
Current Primary Outcome MeasuresChange From Baseline to Endpoint in Weight [Time Frame: Baseline to endpoint (22 weeks)] [Designated as safety issue: Yes]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleAssessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine
Official TitleThe 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
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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Condition
  • Schizophrenia
  • Schizoaffective Disorders
InterventionDrug: 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
Study Arm (s)
  • Experimental: Olanzapine
    olanzapine plus behavioral information
  • Experimental: Olanzapine + Amantadine
    Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
  • Experimental: Olanzapine + Metformin
    Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment199
Estimated Completion DateSeptember 2008
Estimated Primary Completion DateSeptember 2008
Eligibility 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Brazil, Israel, Korea, Republic of, Mexico, Puerto Rico, Russian Federation

Administrative Information[ + expand ][ + ]

NCT Number NCT00401973
Other Study ID Numbers10768
Has Data Monitoring CommitteeNot Provided
Information Provided ByEli Lilly and Company
Study SponsorEli Lilly and Company
CollaboratorsNot Provided
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
Verification DateSeptember 2009

Locations[ + expand ][ + ]

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