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

Primary Purpose

Weight Gain

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lorcaserin
Intensive dietary counseling
Sponsored by
Southern California Institute for Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Gain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA Long BeachRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lorcaserin with intensive diet counseling

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluation of glucose control
Will evaluate lab values for fasting blood glucose, Hemoglobin A1c, and fasting insulin levels
Evaluation of cravings
Using various questionnaires to evaluate cravings of various foods.
Monitoring of mood
Using standard questionnaires to evaluate mental health.
Evaluation of systolic blood pressure
Evaluation of diastolic blood pressure
Evaluation of pulse
Evaluation of body-mass index (BMI)
Evaluation of waist circumference
Evaluation of cholesterol control
Will measure fasting cholesterol labs, which will include total cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL)
Evaluation of electrolytes
Will monitor basic metabolic panel
Evaluation of liver
Will monitor liver enzymes
Evaluation of blood count
Will monitor blood count

Full Information

First Posted
October 8, 2013
Last Updated
January 29, 2014
Sponsor
Southern California Institute for Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT01962402
Brief Title
Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study
Official Title
Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern California Institute for Research and Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lorcaserin with intensive diet counseling
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
lorcaserin
Other Intervention Name(s)
Belviq
Intervention Description
Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Intensive dietary counseling
Intervention Description
All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars.
Primary Outcome Measure Information:
Title
Weight loss
Description
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.
Time Frame
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Secondary Outcome Measure Information:
Title
Evaluation of glucose control
Description
Will evaluate lab values for fasting blood glucose, Hemoglobin A1c, and fasting insulin levels
Time Frame
At initial visit and at week 12 of the study
Title
Evaluation of cravings
Description
Using various questionnaires to evaluate cravings of various foods.
Time Frame
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Title
Monitoring of mood
Description
Using standard questionnaires to evaluate mental health.
Time Frame
At initial visit, then at week 4 and week 12 of the study
Title
Evaluation of systolic blood pressure
Time Frame
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Title
Evaluation of diastolic blood pressure
Time Frame
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Title
Evaluation of pulse
Time Frame
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Title
Evaluation of body-mass index (BMI)
Time Frame
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Title
Evaluation of waist circumference
Time Frame
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Title
Evaluation of cholesterol control
Description
Will measure fasting cholesterol labs, which will include total cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL)
Time Frame
At initial visit and at week 12 of the study
Title
Evaluation of electrolytes
Description
Will monitor basic metabolic panel
Time Frame
At initial visit and at week 12 of the study
Title
Evaluation of liver
Description
Will monitor liver enzymes
Time Frame
At initial visit and at week 12 of the study
Title
Evaluation of blood count
Description
Will monitor blood count
Time Frame
At initial visit and at week 12 of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Shakib, Pharm.D.
Phone
562-826-8000
Ext
4564
Email
susan.shakib@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Nguyen, MD
Phone
562-826-8000
Ext
3160
Facility Information:
Facility Name
VA Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Shakib, Pharm.D.
Phone
562-826-8000
Ext
4564
Email
susan.shakib@va.gov

12. IPD Sharing Statement

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

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