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OpenTrials
Completed

NCT Number: NCT00401973

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary 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, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

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

Other names: LY170053, Zyprexa

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.

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.

zonisamide

Drug

Zonisamide, 100-400mg, oral, daily.

Wellness Education

Behavioral

weight management

Primary outcomes

  1. Change From Baseline to Endpoint in Weight

    Time frame: Baseline to endpoint (22 weeks)

Secondary outcomes

  1. Mean Change From Baseline to Endpoint in Fasting Triglycerides

    Time frame: Baseline to endpoint (22 weeks)

  2. Mean Change From Baseline to Endpoint in Fasting Total Cholesterol

    Time frame: Baseline to endpoint (22 weeks)

  3. Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol

    Time frame: Baseline to endpoint (22 weeks)

  4. Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol

    Time frame: Baseline to endpoint (22 weeks)

  5. Mean Change From Baseline to Endpoint in Fasting Glucose

    Time frame: Baseline to endpoint (22 weeks)

  6. Mean Change From Baseline to Endpoint in Hemoglobin A1c

    Time frame: Baseline to endpoint (22 weeks)

  7. Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score

    Time frame: Baseline to endpoint (22 weeks)

    The BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Each item is rated on a scale from 1 (symptom not present) to 7 (symptom extremely severe). The BPRS total score ranges from 18 to 126.

  8. Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    Time frame: Baseline to endpoint (22 weeks)

    The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).

  9. Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)

    Time frame: Baseline to endpoint (22 weeks)

    Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

  10. 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)

    To understand the drivers of weight gain as indicated by the correlation between weight changes and changes in the Eating Inventory (EI) and Food Craving Inventory (FCI). The EI is a 51-item inventory that measures dietary restraint, disinhibition, and perceived hunger. The FCI is a 28-item instrument measuring the frequency over the past month of general cravings and cravings for specific types of foods, namely: high fats, sweets, carbohydrates/starches, and fast-food fats. Correlations were computed on the combined treatment groups.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 22, 2006
Registry last updated
Oct 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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