Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Diabetes; Weight Gain
MeSH terms: Body Weight; Weight Gain; Weight Loss; Schizophrenia; Psychotic Disorders
Intervention: Pramlintide; Placebo
Intervention description: 180mg subcutaneous injections, twice daily; 180mg subcutaneous injections, twice daily
Intervention MeSH terms: Pramlintide
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Schizoaffective; Olanzapine; Zyprexa; Clozapine; Clozaril; Pramlintide; Diabetes; Weight Gain; Obesity; Metabolic Syndrome

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.
    

Eligibility 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.