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

Study Overview
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Brief Summary
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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.

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

Conditions
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Weight Gain

Intervention / Treatment
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* Drug: lorcaserin
* Behavioral: Intensive dietary counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lorcaserin with intensive diet counseling<br>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<br>* Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.<br>* Other names: Belviq;Behavioral: Intensive dietary counseling<br>* All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars.<br>|

What is the study measuring?
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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 |