Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-06 @ 10:56 PM
Study NCT ID:
NCT01962402
Status:
UNKNOWN
Last Update Posted:
2014-01-30
First Post:
2013-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506658', 'term': 'lorcaserin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-01-29', 'studyFirstSubmitDate': '2013-10-08', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': 'initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of glucose control', 'timeFrame': 'At initial visit and at week 12 of the study', 'description': 'Will evaluate lab values for fasting blood glucose, Hemoglobin A1c, and fasting insulin levels'}, {'measure': 'Evaluation of cravings', 'timeFrame': 'initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study', 'description': 'Using various questionnaires to evaluate cravings of various foods.'}, {'measure': 'Monitoring of mood', 'timeFrame': 'At initial visit, then at week 4 and week 12 of the study', 'description': 'Using standard questionnaires to evaluate mental health.'}, {'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', 'description': 'Will measure fasting cholesterol labs, which will include total cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL)'}, {'measure': 'Evaluation of electrolytes', 'timeFrame': 'At initial visit and at week 12 of the study', 'description': 'Will monitor basic metabolic panel'}, {'measure': 'Evaluation of liver', 'timeFrame': 'At initial visit and at week 12 of the study', 'description': 'Will monitor liver enzymes'}, {'measure': 'Evaluation of blood count', 'timeFrame': 'At initial visit and at week 12 of the study', 'description': 'Will monitor blood count'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Weight Gain']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\n* Patients currently on atypical antipsychotics\n* 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.\n* 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.\n\nEXCLUSION CRITERIA:\n\n* Pregnancy in women or breastfeeding\n* The patient has greater than mild aortic valve regurgitation, or moderate to greater mitral valve regurgitation\n* Known hypersensitivity to lorcaserin\n* The patient is taking another weight loss medication concurrently\n* Dementia\n* Age less than 18 or greater than 65\n* No recent substance abuse within 3 months\n* No suicidal ideation within 3 months\n* Unable to give informed consent, unless patient is conserved, then the conservator can provide informed consent"}, 'identificationModule': {'nctId': 'NCT01962402', 'briefTitle': 'Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Southern California Institute for Research and Education'}, 'officialTitle': 'Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study', 'orgStudyIdInfo': {'id': 'VALB-1259'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lorcaserin with intensive diet counseling', 'description': '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.', 'interventionNames': ['Drug: lorcaserin', 'Behavioral: Intensive dietary counseling']}], 'interventions': [{'name': 'lorcaserin', 'type': 'DRUG', 'otherNames': ['Belviq'], 'description': 'Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.', 'armGroupLabels': ['Lorcaserin with intensive diet counseling']}, {'name': 'Intensive dietary counseling', 'type': 'BEHAVIORAL', 'description': 'All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars.', 'armGroupLabels': ['Lorcaserin with intensive diet counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Susan Shakib, Pharm.D.', 'role': 'CONTACT', 'email': 'susan.shakib@va.gov', 'phone': '562-826-8000', 'phoneExt': '4564'}], 'facility': 'VA Long Beach', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}], 'centralContacts': [{'name': 'Susan Shakib, Pharm.D.', 'role': 'CONTACT', 'email': 'susan.shakib@va.gov', 'phone': '562-826-8000', 'phoneExt': '4564'}, {'name': 'Charles Nguyen, MD', 'role': 'CONTACT', 'phone': '562-826-8000', 'phoneExt': '3160'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern California Institute for Research and Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Psychiatrist', 'investigatorFullName': 'Charles Nguyen', 'investigatorAffiliation': 'Southern California Institute for Research and Education'}}}}