Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study
NCT ID: NCT01962402
Last Updated: 2014-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
15 participants
INTERVENTIONAL
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lorcaserin with intensive diet 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
Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.
Intensive dietary counseling
All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars.
Interventions
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lorcaserin
Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.
Intensive dietary counseling
All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Southern California Institute for Research and Education
OTHER
Responsible Party
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Charles Nguyen
Psychiatrist
Locations
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VA Long Beach
Long Beach, California, United States
Countries
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Central Contacts
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Charles Nguyen, MD
Role: CONTACT
Facility Contacts
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Other Identifiers
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VALB-1259
Identifier Type: -
Identifier Source: org_study_id
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