Recruiting

Lorcaserin

Sponsor:

Southern California Institute for Research and Education

Code:

NCT01962402

Conditions

Weight Gain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

lorcaserin

Intensive dietary counseling

Study Details

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.

Conditions

Weight Gain

Study ID

NCT01962402

Start date

Jan, 2014

Status verified date

Jan, 2014

Primary completion date

Jul, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Weight loss [ Time Frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study ]

Central Contacts and Locations

Central contacts

Susan Shakib, Pharm.D.

562-826-8000susan.shakib@va.gov

Charles Nguyen, MD

562-826-8000

Locations

VA Long Beach

Recruiting

Long Beach, California, United States, 90822

Contacts

Susan Shakib, Pharm.D.

562-826-8000susan.shakib@va.gov

More Information

Sponsor

Southern California Institute for Research and Education

Last update posted

Jan 30, 2014

Last verified

Jan, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Southern California Institute for Research and Education on 2014-01-30.