Back to resultsDemonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia
Primary Purpose
Schizophrenia, Schizoaffective Disorder, Diabetes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pramlintide
Placebo
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective, Olanzapine, Zyprexa, Clozapine, Clozaril, Pramlintide, Diabetes, Weight Gain, Obesity, Metabolic Syndrome
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.
Sites / Locations
- The University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Placebo
Pramlintide
Arm Description
Patients will be given the Placebo for injection twice daily
volunteers are given 180mg of pramlintide, twice daily
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00690235
First Posted
January 27, 2008
Last Updated
November 14, 2018
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Amylin Pharmaceuticals, LLC.
1. Study Identification
Unique Protocol Identification Number
NCT00690235
Brief Title
Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Amylin Pharmaceuticals, LLC.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Diabetes, Weight Gain
Keywords
Schizophrenia, Schizoaffective, Olanzapine, Zyprexa, Clozapine, Clozaril, Pramlintide, Diabetes, Weight Gain, Obesity, Metabolic Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Other
Arm Description
Patients will be given the Placebo for injection twice daily
Arm Title
Pramlintide
Arm Type
Other
Arm Description
volunteers are given 180mg of pramlintide, twice daily
Intervention Type
Drug
Intervention Name(s)
Pramlintide
Other Intervention Name(s)
Amylin
Intervention Description
180mg subcutaneous injections, twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sterile saline
Intervention Description
180mg subcutaneous injections, twice daily
Primary Outcome Measure Information:
Title
Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine
Description
Mean Number of Pounds Lost on Pramlintide Over 16 Weeks
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol A Tamminga, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia
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