MEtformin and Lorcaserin for WeighT Loss in Schizophrenia
Status:
Terminated
Trial end date:
2020-02-14
Target enrollment:
Participant gender:
Summary
Purpose: The purpose of this study is to test new pharmacologic strategies for weight loss in
patients with schizophrenia, a population for which no current weight-loss treatments have
gained widespread use. The goal is to recruit overweight people with schizophrenia to
participate in a 52-week double-blind, randomized study to assess the efficacy and safety of
lorcaserin/metformin combination treatment, lorcaserin monotherapy, and placebo on weight,
body composition, and measures of glucose and lipid metabolism.
Participants: Approximately 110 subjects will be enrolled at four clinical sites (UNC Chapel
Hill, Carolina Behavioral Care, Columbia University, and Augusta University)
Procedures (methods): Behavioral: All participants will be offered a behavioral intervention
of weekly diet and exercise counseling aimed at modifying cardiovascular risk factors. This
intervention will be provided at all in-person study visits after the Baseline Visit and
supplemented with weekly interim phone calls to reinforce lessons between visits.
Pharmacological Intervention: All participants who meet entry criteria will be randomized to
one of the three treatment groups (lorcaserin/metformin, lorcaserin, and placebo).
Phase:
Phase 4
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Columbia University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)