Status:
COMPLETED
Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Primary Objective: To test the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain in persons with schizophrenia who are currently taking either drug; measures of th...
Detailed Description
This study is a sixteen week placebo-controlled, double-blind investigation of the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain. We will recruit approximately ...
Eligibility Criteria
Inclusion
- Volunteers will be males or females 18-65 yrs of age with a diagnosis of schizophrenia or schizoaffective disorder who have a history of significant weight gain with olanzapine or clozapine administration.
- Volunteers will have a current BMI=\>27 but equal to or less than 40.
- Volunteers will have been taking a stable dose (less than 10% dose change) of clozapine or olanzapine or at least two months prior to study start.
- Volunteers will be willing and able to participate in the subcutaneous administration training week prior to study start.
- Able and willing to give informed consent.
Exclusion
- Clinically significant abnormal pre-admission vital signs, positive HIV, or clinical laboratory evaluations, in which the principal investigator deems the subject-volunteer ineligible for the study
- Positive results for infectious diseases and sexually-transmitted diseases will be reported according to the Texas Department of State Health and Texas Administrative Code rules and guidelines
- Any patient with current diabetes mellitus, even if caused by antipsychotic use .
- Patients with active liver disease requiring current treatment. Positive hepatitis C volunteers will only be excluded if they have active liver disease or they have enzyme values are two times the upper limit of normal.
- Any patients with medical disorders that are not properly controlled by medications.
- Pregnant women or women who are breast feeding.
- Patients concomitantly treated with another conventional or second generation antipsychotic medication or with any other anti-obesity drug.
- Mental capacity is limited to the extent that the patient cannot understand the nature of the study along with its risks and benefits.
- Subjects with a high risk of suicide since there is a potential that the study medication will lower the subject's glucose levels.
- Any patient judged by the principal investigator to be inappropriate for the study.
- Known hypersensitivity to study medication or its components
- Non-English speaking
- The clinical assessments that will be used are not available in valid and reliable forms for non-English speaking populations.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00690235
Start Date
November 1 2007
End Date
August 1 2011
Last Update
November 16 2018
Active Locations (1)
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1
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390