Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lorcaserin | Drug | Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of glucose control | Will evaluate lab values for fasting blood glucose, Hemoglobin A1c, and fasting insulin levels | At initial visit and at week 12 of the study |
| Evaluation of cravings |
Not provided
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan Shakib, Pharm.D. | Contact | 562-826-8000 | 4564 | susan.shakib@va.gov |
| Charles Nguyen, MD | Contact | 562-826-8000 | 3160 |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Long Beach | Recruiting | Long Beach | California | 90822 | United States |
Not provided
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C506658 | lorcaserin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intensive dietary counseling | Behavioral | All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars. |
|
Using various questionnaires to evaluate cravings of various foods.
| initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study |
| Monitoring of mood | Using standard questionnaires to evaluate mental health. | 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 |
| Evaluation of pulse | initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study |
| Evaluation of body-mass index (BMI) | initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study |
| 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 | Will measure fasting cholesterol labs, which will include total cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) | At initial visit and at week 12 of the study |
| Evaluation of electrolytes | Will monitor basic metabolic panel | At initial visit and at week 12 of the study |
| Evaluation of liver | Will monitor liver enzymes | At initial visit and at week 12 of the study |
| Evaluation of blood count | Will monitor blood count | At initial visit and at week 12 of the study |