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

Phase 4

• Conditions: Weight Gain
• Interventions: Drug: lorcaserin; Behavioral: Intensive dietary counseling

• Registration Number: NCT01962402
• Lead Sponsor: Southern California Institute for Research and Education

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-14
• Status Verified: 2014-01
• Study Start: 2014-01
• Last Update Submitted: 2014-01-29
• Last Update Posted: 2014-01-30
• Primary Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lorcaserin with intensive diet counseling	Intensive dietary 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.
Lorcaserin with intensive diet counseling	lorcaserin	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.

Primary Outcome Measures

Name	Time	Method
Weight loss	initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VA Long Beach; 🇺🇸 Long Beach, California, United States