Weight Gain
Conditions
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.
Interventions
DRUGlorcaserin
Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.
BEHAVIORALIntensive dietary counseling
All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars.
Sponsors
Southern California Institute for Research and Education
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of cravings | initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study | Using various questionnaires to evaluate cravings of various foods. |
| Monitoring of mood | At initial visit, then at week 4 and week 12 of the study | Using standard questionnaires to evaluate mental health. |
| 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 | — |
| Evaluation of pulse | initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study | — |
| Evaluation of glucose control | At initial visit and at week 12 of the study | Will evaluate lab values for fasting blood glucose, Hemoglobin A1c, and fasting insulin levels |
| Evaluation of waist circumference | initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study | — |
| Evaluation of cholesterol control | At initial visit and at week 12 of the study | Will measure fasting cholesterol labs, which will include total cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) |
| Evaluation of electrolytes | At initial visit and at week 12 of the study | Will monitor basic metabolic panel |
| Evaluation of liver | At initial visit and at week 12 of the study | Will monitor liver enzymes |
| Evaluation of blood count | At initial visit and at week 12 of the study | Will monitor blood count |
| Evaluation of body-mass index (BMI) | initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study | — |
Countries
United States
Contacts
Primary ContactSusan Shakib, Pharm.D.
Backup ContactCharles Nguyen, MD
Outcome results
None listed