NCT00690235

Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Diabetes
• Weight Gain

Interventions

Type	Name	Description
DRUG	Pramlintide	180mg subcutaneous injections, twice daily
DRUG	Placebo	180mg subcutaneous injections, twice daily

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2008-06-04
• Last updated: 2018-11-16
• Results posted: 2018-11-16

Locations

1 site across 1 country: United States