NCT01962402

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

January 30, 2014

Status Verified

January 1, 2014

Enrollment Period

1.5 years

First QC Date

October 8, 2013

Last Update Submit

January 29, 2014

Conditions

Weight Gain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (12)

  • Evaluation of glucose control

    At initial visit and at week 12 of the study

  • Evaluation of cravings

    initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study

  • Monitoring of mood

    At initial visit, then at week 4 and week 12 of the study

  • Evaluation of systolic blood pressure

    initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study

  • Evaluation of diastolic blood pressure

    initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study

  • +7 more secondary outcomes

Study Arms (1)

Lorcaserin with intensive diet counseling

EXPERIMENTAL

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.

Drug: lorcaserinBehavioral: Intensive dietary counseling

Interventions

lorcaserinDRUG

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

Also known as: Belviq
Lorcaserin with intensive diet counseling
Intensive dietary counselingBEHAVIORAL

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

Lorcaserin with intensive diet counseling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Long Beach

Long Beach, California, 90822, United States

RECRUITING

MeSH Terms

Conditions

Weight Gain

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Susan Shakib, Pharm.D.

CONTACT

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

Charles Nguyen, MD

CONTACT

562-826-8000

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 14, 2013

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Last Updated

January 30, 2014

Record last verified: 2014-01

Locations

US(1)