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MEtformin and Lorcaserin for WeighT Loss in Schizophrenia (MELT)

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ClinicalTrials.gov Identifier: NCT02796144
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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 three clinical sites (UNC Chapel Hill, Carolina Behavioral Care and Columbia 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).


Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Overweight Drug: Lorcaserin Drug: Metformin Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metformin and Lorcaserin for Weight Loss in Schizophrenia
Study Start Date : September 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Active Comparator: Lorcaserin and Metformin

Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.

Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.

Drug: Lorcaserin
Max dose of 10 mg BID
Other Name: Belviq

Drug: Metformin
Max dose of 1,000 mg BID
Other Name: Glumetza, Riomet, Glucophage, and Fortamet

Active Comparator: Lorcaserin
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Drug: Lorcaserin
Max dose of 10 mg BID
Other Name: Belviq

Placebo Comparator: Placebo
Matching placebos will be administered for each active drug.
Drug: Placebo
Matching placebos will be administered for each drug.
Other Name: Sugar pill




Primary Outcome Measures :
  1. Mean Difference in Body Weight Change Between Participants Assigned to lorcaserin/metformin combination treatment and placebo [ Time Frame: Measured at the last study visit (Up to 52 weeks) ]
    Mean difference in body weight change between participants assigned to lorcaserin/metformin combination treatment and participants assigned to placebo from baseline to last study visit (up to 52 weeks)


Secondary Outcome Measures :
  1. Mean Difference in Body Weight Change Between Participants Assigned to lorcaserin monotherapy treatment and placebo [ Time Frame: Measured at the last study visit (Up to 52 weeks) ]
    Mean difference in body weight change between participants assigned to lorcaserin monotherapy treatment and participants assigned to placebo from baseline to last study visit (up to 52 weeks)

  2. Change in HDL Cholesterol From Baseline to 52 Weeks [ Time Frame: 52 Weeks ]
    high-density lipoprotein

  3. Change in LDL Cholesterol From Baseline to 52 Weeks [ Time Frame: 52 Weeks ]
    low-density lipoprotein

  4. Change in Triglycerides From Baseline to 52 Weeks [ Time Frame: 52 Weeks ]
    serum triglycerides

  5. Change in Total Cholesterol From Baseline to 52 Weeks [ Time Frame: 52 Weeks ]
    Total Cholesterol

  6. Change in Hemoglobin A1c From Baseline to 52 Weeks [ Time Frame: 52 Weeks ]
    glycosylated hemoglobin

  7. Change in Fasting Glucose From Baseline to 52 Weeks [ Time Frame: 52 weeks ]
    fasting blood glucose



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients with a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria (see Appendix 3 and Appendix 4) and confirmed by the Structured Clinical Interview for DSM-IV (SCID).
  • Duration of psychotic illness must be greater than one year, as defined by having initiated antipsychotic treatment at least 1 year prior to study enrollment.
  • Must be 18-65 years of age.
  • Must demonstrate adequate decisional capacity to make a choice about participating in this research study and must provide written informed consent to participate.
  • BMI greater than or equal to 27 kg/m2
  • Currently treated with one or a combination of two FDA-approved antipsychotic medications (typical or atypical antipsychotics) AND on that drug regimen for at least two months prior to study entry (with stable dosages for at least 1 month).
  • Concomitant medications are allowed if agents and doses are unchanged for at least 1 month prior to study entry and if these medications are not among those excluded in the Exclusion Criteria.
  • Women who can become pregnant must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. Acceptable methods include oral, injectable or implanted contraceptives, intrauterine devices or barrier methods such as condoms, diaphragm and spermicides. Women who can become pregnant must have a negative serum pregnancy test at the Screening Visit.

Exclusion Criteria:

  • Inpatient status
  • Clinical Global Impression Severity (CGI-S) score greater than or equal to 6
  • Current treatment with more than 2 antipsychotics
  • HbA1c greater than or equal to 6.5%
  • 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 or prior treatment with a 5-HT2B agonist (e.g. cabergoline) within the past 45 days due to potential risk for heart valve defects
  • Current treatment with two or more antidepressants
  • Current treatment with a single antidepressant prescribed in excess of the maximum approved dose
  • Current treatment with monoamine oxidase inhibitor (MAOI) class of antidepressants (isocarboxazid, phenelzine, selegiline, tranylcypromine)
  • Concurrent treatment with any of the following pro-serotonergic drugs: meperidine, buspirone, dextromethorphan, triptans, tramadol, ritonavir, tryptophan, ginseng, St. John's wort
  • Diagnosis of congestive heart failure
  • Uncorrected thyroid disorder
  • Renal impairment as evidenced by estimated glomerular filtration rate (eGFR) 50 mL/min/1.73 m2
  • Hepatic disease (ALT, AST, or GGT > 2 times upper limit of normal (ULN), total bilirubin > 1.2 times ULN)
  • Metabolic acidosis (serum CO2 <20 mEq/L)
  • Known hypersensitivity to metformin or lorcaserin
  • Women who are pregnant or breastfeeding
  • Recent (in the past 30 days) or scheduled radiological studies involving iodinated contrast material
  • Alcohol abuse/dependence as determined by SCID within the past month
  • Other serious and unstable medical condition in the judgment of the investigator
  • DSM-IV diagnosis of mental retardation or dementia
  • Any medication (prescription or non-prescription) used for weight loss must have been discontinued 3 months prior to study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796144


Contacts
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Contact: Lars F. Jarskog, MD 919-843-7683 lars_jarskog@med.unc.edu
Contact: Scott Stroup, MD, MPH 646 774 8435 stroups@nyspi.columbia.edu

Locations
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United States, New York
New York State Psychiatric Institute (NYSPI), Columbia University Recruiting
New York, New York, United States, 11032
Contact: Scott Stroup, MD, MPH    646-774-8435    stroups@nyspi.columbia.edu   
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Lars F Jarskog, MD    919-843-7683    lars_jarskog@med.unc.edu   
Carolina Behavioral Care Recruiting
Hillsborough, North Carolina, United States, 27278
Contact: Robert Millet, MD       rmillet@carolinabehavioralcare.com   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Lars F. Jarskog, MD University of North Carolina, Chapel Hill

Publications:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02796144     History of Changes
Other Study ID Numbers: 15-1998
1R01DK105526-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of North Carolina, Chapel Hill:
schizophrenia
schizoaffective disorder
overweight
obesity
weight loss
metformin
lorcaserin
Additional relevant MeSH terms:
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Overweight
Weight Loss
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Body Weight
Signs and Symptoms
Body Weight Changes
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs