Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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 the metabolic syndrome will be evaluated as well.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Amylin Pharmaceuticals, LLC.
• Treatments: Clozapine; Islet Amyloid Polypeptide; Olanzapine; Pramlintide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.