Phase 4
Completed N=33
Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia
Source: ClinicalTrials.gov NCT00690235 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine — 37; 40.5 pounds
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine |
37; 40.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00690235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.