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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00401973
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : September 30, 2009
Last Update Posted : October 6, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 17, 2006
First Posted Date  ICMJE November 22, 2006
Results First Submitted Date  ICMJE August 27, 2009
Results First Posted Date  ICMJE September 30, 2009
Last Update Posted Date October 6, 2009
Study Start Date  ICMJE November 2006
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2009)
Change From Baseline to Endpoint in Weight [ Time Frame: Baseline to endpoint (22 weeks) ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2006)
mean weight change from baseline to week 22
Change History Complete list of historical versions of study NCT00401973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2009)
  • Mean Change From Baseline to Endpoint in Fasting Triglycerides [ Time Frame: Baseline to endpoint (22 weeks) ]
  • Mean Change From Baseline to Endpoint in Fasting Total Cholesterol [ Time Frame: 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) ]
  • Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Baseline to endpoint (22 weeks) ]
  • Mean Change From Baseline to Endpoint in Fasting Glucose [ Time Frame: Baseline to endpoint (22 weeks) ]
  • Mean Change From Baseline to Endpoint in Hemoglobin A1c [ Time Frame: 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) ]
  • Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2006)
difference in mean changes from baseline to week 22 in triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, fasting glucose, and Hemoglobin A1c mean changes from baseline to week 22 in the BPRS, MADRS, and CGI-S.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine
Official Title  ICMJE 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
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorders
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Olanzapine
    olanzapine plus behavioral information
    Interventions:
    • Drug: olanzapine
    • Behavioral: Wellness education
  • Experimental: Olanzapine + Amantadine
    Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
    Interventions:
    • Drug: olanzapine
    • Drug: amantadine
    • Drug: metformin
    • Drug: zonisamide
    • Behavioral: Wellness education
  • Experimental: Olanzapine + Metformin
    Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information
    Interventions:
    • Drug: olanzapine
    • Drug: amantadine
    • Drug: metformin
    • Drug: zonisamide
    • Behavioral: Wellness education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2009)
199
Original Enrollment  ICMJE
 (submitted: November 17, 2006)
200
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Israel,   Korea, Republic of,   Mexico,   Puerto Rico,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00401973
Other Study ID Numbers  ICMJE 10768
F1D-US-HGMM
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP