Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia (NCT00690235) | Clinical Trial Compass
CompletedPhase 4
Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia
United States33 participantsStarted 2007-11
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 concomi…
What they're measuring
1
Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine
Timeframe: 16 weeks
Trial details
NCT IDNCT00690235
SponsorUniversity of Texas Southwestern Medical Center