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MEtformin and Lorcaserin for WeighT Loss in Schizophrenia (MELT)

University of North Carolina at Chapel Hill


Description

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.


Keywords:

Mental Health, Nutrition, Obesity


Category:

Drug or Biologic

Qualifications

 


Age
18 - 65 years


Gender
Any


Study Population

People with Schizophrenia or Schizoaffective disorder.


Investigator

Fred Jarskog
Clinical Professor
Psychiatry - General

For questions, contact:

Tonya Elliott
tonya_elliott@med.unc.edu
(919) 966-3915


Recruitment Period End

March 31, 2020

Location

Primary Location
UNC Hospital in Chapel Hill

Secondary Location
North Carolina Psychiatric Research Center
3010 Falstaff Rd, Raleigh, NC 27610, USA

Study Qualifications

Gender Any

Age Range 18 - 65 years

Participant qualification(s) Outpatients with a diagnosis of schizophrenia or schizoaffective disorder Duration of psychotic illness must be greater than one year BMI >= 27 kg/m2 Currently treated with one or a combination of two FDA-approved antipsychotic medications

Not eligible if: Inpatient status Current treatment with more than 2 antipsychotics Diagnosis of diabetes mellitus or current treatment with insulin or oral hypoglycemics Current or prior treatment with metformin within the past 3 months Current or prior treatment with lorcaserin within the past 3 months Current treatment with two or more antidepressants Current treatment with monoamine oxidase inhibitor (MAOI) class of antidepressants (isocarboxazid, phenelzine, selegiline, tranylcypromine) Diagnosis of congestive heart failure Uncorrected thyroid disorder

Number of Visits

    » 17 In person visit(s)

    1 screening, 16 clinic, 2 optional DXA scan visits

    » 15 Remote visit(s)

    15 phone call visits (10-15 minutes) scheduled between in-person study visits

Participation Period

52 weeks

Compensation

$45 Visa gift card at each visit, $5 cash for returned meds at each study visit, $25 Visa gift card for optional DXA scan

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.