Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study

The purpose of this study is to determine whether lorcaserin is effective for weight reduction in patients with weight gain as a result of antipsychotic medications.

Study Overview

• Status: Unknown
• Conditions: Weight Gain
• Intervention / Treatment: Drug: lorcaserin; Behavioral: Intensive dietary counseling

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90822
      • Recruiting
      • VA Long Beach
      • Contact: Susan Shakib, Pharm.D.; Phone Number: 4564 562-826-8000; Email: susan.shakib@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA:

• Patients currently on atypical antipsychotics
• The patient's BMI is greater than or equal to 30 kg/m2 OR the patient's BMI is greater than or equal to 27 kg/m2 in the presence of at least one weight-related co-morbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, metabolic syndrome, obstructive sleep apnea, or degenerative joint disease such as osteoarthritis.
• Patient agreeable to follow up with provider at the scheduled appointments at week 1, week 2, week 4, week 8, week 12 and week 16 after initiation of medication.

EXCLUSION CRITERIA:

• Pregnancy in women or breastfeeding
• The patient has greater than mild aortic valve regurgitation, or moderate to greater mitral valve regurgitation
• Known hypersensitivity to lorcaserin
• The patient is taking another weight loss medication concurrently
• Dementia
• Age less than 18 or greater than 65
• No recent substance abuse within 3 months
• No suicidal ideation within 3 months
• Unable to give informed consent, unless patient is conserved, then the conservator can provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lorcaserin with intensive diet counseling; Patients will be taking lorcaserin 10mg tablet by mouth twice daily. In addition, patients will be provided with intensive dietary counseling to promote weight loss.	Drug: lorcaserin; Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.; Other Names: Belviq; Behavioral: Intensive dietary counseling; All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	The primary objective of this study is to evaluate the effectiveness of lorcaserin for weight loss management in patients on an antipsychotic agent. Will monitor the weight of the patient for evaluation.	initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of glucose control	Will evaluate lab values for fasting blood glucose, Hemoglobin A1c, and fasting insulin levels	At initial visit and at week 12 of the study
Evaluation of cravings	Using various questionnaires to evaluate cravings of various foods.	initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Monitoring of mood	Using standard questionnaires to evaluate mental health.	At initial visit, then at week 4 and week 12 of the study
Evaluation of systolic blood pressure		initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of diastolic blood pressure		initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of pulse		initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of body-mass index (BMI)		initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of waist circumference		initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of cholesterol control	Will measure fasting cholesterol labs, which will include total cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL)	At initial visit and at week 12 of the study
Evaluation of electrolytes	Will monitor basic metabolic panel	At initial visit and at week 12 of the study
Evaluation of liver	Will monitor liver enzymes	At initial visit and at week 12 of the study
Evaluation of blood count	Will monitor blood count	At initial visit and at week 12 of the study

Collaborators and Investigators

• Sponsor: Southern California Institute for Research and Education

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 14, 2013

Study Record Updates

• Last Update Posted (Estimate): January 30, 2014
• Last Update Submitted That Met QC Criteria: January 29, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight; Weight Gain
• Other Study ID Numbers: VALB-1259