Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia
Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder; Diabetes; Weight Gain
Intervention: Pramlintide (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s): Carol A Tamminga, MD, Principal Investigator, Affiliation: UT Southwestern Medical Center
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.
Secondary Objective To evaluate the action of pramlintide on cognition in schizophrenia and
on psychotic symptoms of the illness.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Weight loss with pramlintide in persons with schizophrenia who have gained weight taking olanzapine or clozapine
Secondary outcome: Improve cognition in persons with schizophrenia
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
The University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States
Additional Information
Starting date: November 2007
Last updated: June 21, 2012
|