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

Southern California Institute for Research and Education

Status and phase: Unknown; Phase 4

Conditions: Weight Gain

Treatments: Behavioral: Intensive dietary counseling; Drug: lorcaserin

Study type: Interventional

Funder types: Other

Identifiers

NCT01962402

VALB-1259

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Lorcaserin with intensive diet counseling

Experimental group

Description:

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.

Treatment:

Drug: lorcaserin

Behavioral: Intensive dietary counseling