Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia

NCT00690235 | Completed Phase 4 Results DMC

• 1 other identifier: 092007-025
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Schizoaffective Disorder; Diabetes; Weight Gain

Keywords

Schizophrenia; Schizoaffective; Olanzapine; Zyprexa; Clozapine; Clozaril; Pramlintide; Diabetes; Weight Gain; Obesity; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine

  Mean Number of Pounds Lost on Pramlintide Over 16 Weeks

  16 weeks

Study Arms (2)

Placebo

OTHER

Patients will be given the Placebo for injection twice daily

Drug: Placebo

Pramlintide

OTHER

volunteers are given 180mg of pramlintide, twice daily

Drug: Pramlintide

Interventions

Pramlintide DRUG

180mg subcutaneous injections, twice daily

Also known as: Amylin

Pramlintide

Placebo DRUG

180mg subcutaneous injections, twice daily

Also known as: sterile saline

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Amylin Pharmaceuticals, LLC.: collaborator

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Diabetes Mellitus; Weight Gain; Obesity; Metabolic Syndrome

Interventions

pramlintide; Islet Amyloid Polypeptide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Amyloidogenic Proteins; Amyloid; Proteins

Results Point of Contact

• Title: Carol A. Tamminga, MD
• Organization: University of Texas Southwestern Medical Center

carol.tamminga@utsouthwestern.edu

214-645-2789

Study Officials

• Carol A Tamminga, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2008
• First Posted: June 4, 2008
• Study Start: November 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 16, 2018
• Results First Posted: November 16, 2018

Record last verified: 2018-11

Locations

US (1)