Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Carol A. Tamminga, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00690235
First received: January 27, 2008
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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.

Secondary Objective To evaluate the action of pramlintide on cognition in schizophrenia and on psychotic symptoms of the illness.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Diabetes
Weight Gain
Drug: Pramlintide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Effects of Pramlintide on Weight Reduction in Clozapine- and Olanzapine-Induced Weight Gain in Obese People Diagnosed With Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Weight loss with pramlintide in persons with schizophrenia who have gained weight taking olanzapine or clozapine [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improve cognition in persons with schizophrenia [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: November 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2
Patients will be given the Placebo for injection twice daily
Drug: Placebo
180mg subcutaneous injections, twice daily
Other Name: sterile saline
1
volunteers are given 180mg of pramlintide, twice daily
Drug: Pramlintide
180mg subcutaneous injections, twice daily
Other Name: Amylin

Detailed Description:

This study is a sixteen week placebo-controlled, double-blind investigation of the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain. We will recruit approximately 72 volunteers with the plan of having a final N = 25 in each of the 2 treatment groups. (This number is to allow for normal attrition in this patient population. If needed, we will recruit more than 72 volunteers in order to achieve the appropriate number of completed subjects.) Patients will be recruited from the local Dallas public and VA mental health systems as volunteers for this study. This study is anticipated to last 20 weeks (2 weeks lead-in [approximately 2-3 visits], 1 week training [4 visits], 16 weeks active drug/placebo [one visit per week for the first 4 weeks, then one visit every 2 weeks for the remainder], and one week follow-up [one visit]. Please see attached chart for more details about each visit.) Volunteers will have to have a history of significant weight gain accompanying olanzapine or clozapine treatment and have a BMI=>27 and =<40. Each volunteer will be maintained on their optimal dose of clozapine or olanzapine and be randomized blindly to pramlintide or placebo. Pramlintide will be administered by the patients in a self-injectable form and dosing will begin at 180 mcg bid for 2 weeks and then increase to 360 mcg bid for the remainder of the study. The randomization to pramlintide/placebo will be preceded by a week-long self-administration training program using placebo for pramlintide (with additional information regarding nutrition, exercise, general self-care, and risk factors for diabetes being provided to the patients during this training program). In addition to body weight, BMI and other measures of the metabolic syndrome will be collected. Moreover, the effect of pramlintide on cognitive dysfunction in schizophrenia will be assessed as secondary outcomes, as well as its effect on psychotic symptoms.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690235

Locations
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: Carol A Tamminga, MD UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Carol A. Tamminga, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00690235     History of Changes
Other Study ID Numbers: 092007-025
Study First Received: January 27, 2008
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Schizophrenia
Schizoaffective
Olanzapine
Zyprexa
Clozapine
Clozaril
Pramlintide
Diabetes
Weight Gain
Obesity
Metabolic Syndrome

Additional relevant MeSH terms:
Diabetes Mellitus
Psychotic Disorders
Schizophrenia
Weight Gain
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Clozapine
Olanzapine
Islet Amyloid Polypeptide
Pramlintide
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists

ClinicalTrials.gov processed this record on August 21, 2014