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

NCT ID: NCT01962402

Last Updated: 2014-01-30

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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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

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Conditions

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Weight Gain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

lorcaserin

Intervention Type DRUG

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

Intensive dietary counseling

Intervention Type BEHAVIORAL

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.

Intervention Type DRUG

Intensive dietary counseling

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Belviq

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southern California Institute for Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Charles Nguyen

Psychiatrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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VA Long Beach

Long Beach, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Susan Shakib, Pharm.D.

Role: CONTACT

562-826-8000 ext. 4564

Charles Nguyen, MD

Role: CONTACT

562-826-8000 ext. 3160

Facility Contacts

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Susan Shakib, Pharm.D.

Role: primary

562-826-8000 ext. 4564

Other Identifiers

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VALB-1259

Identifier Type: -

Identifier Source: org_study_id

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