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Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01962402
Recruitment Status : Unknown
Verified January 2014 by Charles Nguyen, Southern California Institute for Research and Education.
Recruitment status was:  Recruiting
First Posted : October 14, 2013
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):
Charles Nguyen, Southern California Institute for Research and Education

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.

Condition or disease Intervention/treatment Phase
Weight Gain Drug: lorcaserin Behavioral: Intensive dietary counseling Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study
Study Start Date : January 2014
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Lorcaserin

Arm Intervention/treatment
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.
Drug: lorcaserin
Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.
Other Name: Belviq

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




Primary Outcome Measures :
  1. Weight loss [ Time Frame: 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 Outcome Measures :
  1. Evaluation of glucose control [ Time Frame: At initial visit and at week 12 of the study ]
    Will evaluate lab values for fasting blood glucose, Hemoglobin A1c, and fasting insulin levels

  2. Evaluation of cravings [ Time Frame: 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.

  3. Monitoring of mood [ Time Frame: At initial visit, then at week 4 and week 12 of the study ]
    Using standard questionnaires to evaluate mental health.

  4. Evaluation of systolic blood pressure [ Time Frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study ]
  5. Evaluation of diastolic blood pressure [ Time Frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study ]
  6. Evaluation of pulse [ Time Frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study ]
  7. Evaluation of body-mass index (BMI) [ Time Frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study ]
  8. Evaluation of waist circumference [ Time Frame: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study ]
  9. Evaluation of cholesterol control [ Time Frame: 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)

  10. Evaluation of electrolytes [ Time Frame: At initial visit and at week 12 of the study ]
    Will monitor basic metabolic panel

  11. Evaluation of liver [ Time Frame: At initial visit and at week 12 of the study ]
    Will monitor liver enzymes

  12. Evaluation of blood count [ Time Frame: At initial visit and at week 12 of the study ]
    Will monitor blood count



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962402


Contacts
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Contact: Susan Shakib, Pharm.D. 562-826-8000 ext 4564 susan.shakib@va.gov
Contact: Charles Nguyen, MD 562-826-8000 ext 3160

Locations
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United States, California
VA Long Beach Recruiting
Long Beach, California, United States, 90822
Contact: Susan Shakib, Pharm.D.    562-826-8000 ext 4564    susan.shakib@va.gov   
Sponsors and Collaborators
Southern California Institute for Research and Education

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Responsible Party: Charles Nguyen, Psychiatrist, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT01962402    
Other Study ID Numbers: VALB-1259
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: January 30, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Weight Gain
Signs and Symptoms
Body Weight Changes
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs