Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Metformin
Amantadine hydrochloride
Amantadine
Metformin hydrochloride
Zonisamide
Olanzapine
Olanzapine pamoate
U.S. FDA Resources
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:
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:
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:
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 May 16, 2013