Clinical trial NCT01962402: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Weight Gain
Lead sponsor: Southern California Institute for Research and Education
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight loss
timeFrame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Secondary outcomes:
measure: Evaluation of glucose control
timeFrame: At initial visit and at week 12 of the study
measure: Evaluation of cravings
timeFrame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
measure: Monitoring of mood
timeFrame: At initial visit, then at week 4 and week 12 of the study
measure: Evaluation of systolic blood pressure
timeFrame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
measure: Evaluation of diastolic blood pressure
timeFrame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
measure: Evaluation of pulse
timeFrame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
measure: Evaluation of body-mass index (BMI)
timeFrame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
measure: Evaluation of waist circumference
timeFrame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
measure: Evaluation of cholesterol control
timeFrame: At initial visit and at week 12 of the study
measure: Evaluation of electrolytes
timeFrame: At initial visit and at week 12 of the study
measure: Evaluation of liver
timeFrame: At initial visit and at week 12 of the study
measure: Evaluation of blood count
timeFrame: At initial visit and at week 12 of the study
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach
state: California
Study officials:
References: