At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 33 enrolled
Drug / intervention
Pramlintide +1 moredrug
Likely dose
Pramlintide 180mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
University of Texas Southwestern Medical Center·interventional·Posted Jun 4, 2008·Updated Nov 16, 2018
In Brief
A Phase 4 clinical trial evaluating Pramlintide and Placebo for Schizophrenia and 3 related conditions. Completed, enrolled 33 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder, Diabetes, Weight Gain
CountriesUnited States
CollaboratorsAmylin Pharmaceuticals, LLC.
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
First PostedJun 2008
Primary CompletionAug 2011
TodayJul 2026
First PostedJun 4, 2008
Enrollment StartNov 1, 2007
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.1 years ago
Interventions
Pramlintidedrug
180mg subcutaneous injections, twice daily
Placebodrug
180mg subcutaneous injections, twice daily