MEtformin and Lorcaserin for WeighT Loss in Schizophrenia

NCT02796144 | Terminated Phase 4 Results DMC

• 2 other identifiers: 15-19981R01DK105526-01A1
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 4

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 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).

Conditions

Schizophrenia; Schizoaffective Disorder; Overweight

Keywords

schizophrenia; schizoaffective disorder; overweight; obesity; weight loss; metformin; lorcaserin

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight in Participants Assigned to Lorcaserin/Metformin Combination Treatment and Placebo

  Change in body weight in participants assigned to lorcaserin/metformin combination treatment and participants assigned to placebo from baseline to last study visit (up to 52 weeks)

  Baseline, Last Observed Visit (Up to 52 weeks)

Secondary Outcomes (7)

• Change in Body Weight in Participants Assigned to Lorcaserin Monotherapy Treatment and Placebo

  Baseline, Last Observed Visit (Up to 52 weeks)

• Change in HDL Cholesterol

  Baseline, Last Observed Visit (Up to 52 weeks)

• Change in LDL Cholesterol

  Baseline, Last Observed Visit (Up to 52 weeks)

• Change in Triglycerides

  Baseline, Last Observed Visit (Up to 52 weeks)

• Change in Total Cholesterol

  Baseline, Last Observed Visit (Up to 52 weeks)

Study Arms (3)

Lorcaserin and Metformin

ACTIVE COMPARATOR

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; Drug: Metformin

Lorcaserin

ACTIVE COMPARATOR

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

Drug: Lorcaserin

Placebo

PLACEBO COMPARATOR

Matching placebos will be administered for each active drug.

Drug: Placebo

Interventions

Lorcaserin DRUG

Max dose of 10 mg BID

Also known as: Belviq

Lorcaserin; Lorcaserin and Metformin

Metformin DRUG

Max dose of 1,000 mg BID

Also known as: Glumetza, Riomet, Glucophage, and Fortamet

Lorcaserin and Metformin

Placebo DRUG

Matching placebos will be administered for each drug.

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/m\^2
• 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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Columbia University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (4)

Augusta University

Augusta, Georgia, 30912, United States

Location

New York State Psychiatric Institute (NYSPI), Columbia University

New York, New York, 11032, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Carolina Behavioral Care

Hillsborough, North Carolina, 27278, United States

Location

Related Publications (3)

• Brar JS, Ganguli R, Pandina G, Turkoz I, Berry S, Mahmoud R. Effects of behavioral therapy on weight loss in overweight and obese patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2005 Feb;66(2):205-12. doi: 10.4088/jcp.v66n0208.

  PMID: 15705006 BACKGROUND

• Jarskog LF, Hamer RM, Catellier DJ, Stewart DD, Lavange L, Ray N, Golden LH, Lieberman JA, Stroup TS; METS Investigators. Metformin for weight loss and metabolic control in overweight outpatients with schizophrenia and schizoaffective disorder. Am J Psychiatry. 2013 Sep;170(9):1032-40. doi: 10.1176/appi.ajp.2013.12010127.

  PMID: 23846733 BACKGROUND

• Stroup TS, McEvoy JP, Ring KD, Hamer RH, LaVange LM, Swartz MS, Rosenheck RA, Perkins DO, Nussbaum AM, Lieberman JA; Schizophrenia Trials Network. A randomized trial examining the effectiveness of switching from olanzapine, quetiapine, or risperidone to aripiprazole to reduce metabolic risk: comparison of antipsychotics for metabolic problems (CAMP). Am J Psychiatry. 2011 Sep;168(9):947-56. doi: 10.1176/appi.ajp.2011.10111609. Epub 2011 Jul 18.

  PMID: 21768610 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Overweight; Obesity; Weight Loss

Interventions

lorcaserin; Metformin; Sugars

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Lars Fredrik Jarskog, MD
• Organization: University of North Carolina at Chapel Hill

lars_jarskog@med.unc.edu

919-843-7683

Study Officials

• Lars F. Jarskog, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 10, 2016
• Study Start: September 1, 2016
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: March 3, 2021
• Results First Posted: February 5, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)