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

Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01962402
• Other study ID #: VALB-1259
• Status: Recruiting
• Phase: Phase 4
• First received: October 8, 2013
• Last updated: January 29, 2014
• Start date: January 2014

Study information

• Verified date: January 2014
• Source: Southern California Institute for Research and Education
• Contact: Susan Shakib, Pharm.D.
• Phone: 562-826-8000
• Email: susan.shakib[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Weight Gain

Intervention

Drug:
• lorcaserin
Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.

Behavioral:
• Intensive dietary counseling
All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars.

Locations

Country	Name	City	State
United States	VA Long Beach	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Southern California Institute for Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Monitoring of mood	Using standard questionnaires to evaluate mental health.	At initial visit, then at week 4 and week 12 of the study	No
Secondary	Evaluation of systolic blood pressure		initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study	No
Secondary	Evaluation of diastolic blood pressure		initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study	No
Secondary	Evaluation of pulse		initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study	No
Secondary	Evaluation of body-mass index (BMI)		initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study	No
Secondary	Evaluation of waist circumference		initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study	No
Secondary	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	No
Secondary	Evaluation of electrolytes	Will monitor basic metabolic panel	At initial visit and at week 12 of the study	No
Secondary	Evaluation of liver	Will monitor liver enzymes	At initial visit and at week 12 of the study	No
Secondary	Evaluation of blood count	Will monitor blood count	At initial visit and at week 12 of the study	No