Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder, Diabetes, Weight Gain

In brief

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.

Key facts

Study ID

NCT00690235

Run by

University of Texas Southwestern Medical Center

People needed

33

Starts

2007-11-01

Expected to finish

2011-08-01

Last updated by the study team

2018-11-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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