Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT00709202
Status:
COMPLETED
Last Update Posted:
2019-01-25
First Post:
2008-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001621', 'term': 'Betahistine'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.smith@nki.rfmh.org', 'phone': '845-398-6531', 'title': 'Dr. Robert C Principal Investigator. Smith,', 'organization': 'Nathan Kline Institute for Psychiatric Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks during study drug administration', 'description': 'We are reporting adverse events reported to IRB (Institutional Review Board) on adverse event forms.', 'eventGroups': [{'id': 'EG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 2, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nPlacebo Oral Tablet', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 4, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'notes': 'Vomited after session which included drinking vanilla milkshake. No sequelae.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'conjunctivitis', 'notes': 'Conjunctivitis (Pink Eye) developed in week 2 of study. Successfully treated with Ciprofloxacin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain', 'notes': 'Chest pain and shortness of breath. Medical examination and labs for pulmonary embolism and cardiac enzymes levels were normal..', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'skin rash', 'notes': 'Exfoliated skin rash over sun exposed neck area.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain', 'notes': 'Patient was psychiatrically evaluated for what mother described as difficult behavior after sexual assault.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase in level of psychiatric symptoms', 'notes': 'Patient had increase in level of hallucinations, unusual thought content, and suspicious on Brief Psychiatric Rating Scale.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nPlacebo Oral Tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0021', 'spread': '0.7970', 'groupId': 'OG000'}, {'value': '-1.5490', 'spread': '0.7650', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period', 'description': 'Least Squares estimated change in weight from end of study minus baseline', 'unitOfMeasure': 'kg. (killograms)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Least Squares estimated change in weight from end of study minus baseline for all subjects who had at least one post-baseline weight evaluation, using mixed model analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nPlacebo Oral Tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5524', 'spread': '0.2747', 'groupId': 'OG000'}, {'value': '-0.5637', 'spread': '0.2653', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in BMI from end of study minus baseline', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Least Squares estimated change in BMI from end of study minus baseline for all subjects who had at least one post-baseline weight evaluation, using mixed model analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nPlacebo: Subjects will be receive placebo tablets matched in number to betahistine tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0928', 'spread': '1.3884', 'groupId': 'OG000'}, {'value': '2.4864', 'spread': '1.3669', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in waist circumference from end of study minus baseline', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hip Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nPlacebo: Subjects will be receive placebo tablets matched in number to betahistine tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7957', 'spread': '1.3837', 'groupId': 'OG000'}, {'value': '1.3668', 'spread': '1.3118', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in hip circumference from end of study minus baseline', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nPlacebo: Subjects will be receive placebo tablets matched in number to betahistine tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '4.292', 'spread': '2.116', 'groupId': 'OG000'}, {'value': '3.136', 'spread': '2.116', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in glucose from end of study minus baseline', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nPlacebo: Subjects will be receive placebo tablets matched in number to betahistine tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '1.087', 'spread': '0.079', 'groupId': 'OG000'}, {'value': '1.010', 'spread': '0.079', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in cholesterol from end of study minus baseline', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in LDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nPlacebo: Subjects will be receive placebo tablets matched in number to betahistine tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '1.799', 'spread': '6.633', 'groupId': 'OG000'}, {'value': '0.915', 'spread': '6.633', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in LDL from end of study minus baseline', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in HDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nPlacebo: Subjects will be receive placebo tablets matched in number to betahistine tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '2.555', 'spread': '1.815', 'groupId': 'OG000'}, {'value': '-0.840', 'spread': '1.815', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in HDL from end of study minus baseline', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nPlacebo: Subjects will be receive placebo tablets matched in number to betahistine tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.426', 'spread': '11.119', 'groupId': 'OG000'}, {'value': '-3.360', 'spread': '11.119', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in triglycerides from end of study minus baseline', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Appetite Hunger', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nPlacebo: Subjects will be receive placebo tablets matched in number to betahistine tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.605', 'spread': '.896', 'groupId': 'OG000'}, {'value': '-3.684', 'spread': '.813', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured at baseline and 12 weeks', 'description': 'Least Squares estimated change in appetite hunger from end of study minus baseline.The scale used has no specific name. It is a Visual Analogue Scale, where a line is drawn of 10 cm long with the statement beneath the line" How Hungry do you feel \'. The subject places an X on the line. The measurements, the number of centimeters from the start of the line ("O"), indicate the amount of hunger. The higher the cm number the higher the feeling of hunger. The measure reported is the difference in this scale reading in cm from after the test meal to before consuming the test meal. The number (mean, s.e.m) presented is the analysis of covariance model estimated difference score at the end of study, with the covariate of the same score at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Appetite Fullness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nPlacebo: Subjects will be receive placebo tablets matched in number to betahistine tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '1.800', 'spread': '1.058', 'groupId': 'OG000'}, {'value': '4.698', 'spread': '.925', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '.Measured at baseline and 12 weeks', 'description': 'Least Squares estimated change in appetite fullness from end of study minus baseline.The scale used has no specific name. It is a Visual Analogue Scale, where a line is drawn of 10 cm long with the statement beneath the line" How full do you feel \'. The subject places an X on the line. The measurements, the number of centimeters from the start of the line ("O"). indicate amount of feeling of fullness. The higher the cm number the higher the feeling of fullness. The measure reported is the difference in this scale reading in cm from after the test meal to before consuming the test meal. The number (mean, s.e.m.) presented is the analysis of covariance model estimated difference score at the end of study, with the covariate of the same score at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nPlacebo: Subjects will be receive placebo tablets matched in number to betahistine tablets'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': '48 subjects signed consent for the study. 8 subjects withdrew consent before randomization and another subject withdrew before the first post-baseline measurement. Therefore, only 39 subjects were analyzed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Betahistine', 'description': 'Subjects assigned to this arm will receive Betahistine.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Subjects in this group will received placebo.\n\nBetahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'spread': '14.9', 'groupId': 'BG000'}, {'value': '31.1', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '31.1', 'spread': '14.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data is presented on 39 subjects who had data sufficient data for analysis of variables of clinical interest-who received at least one post baseline evaluation. One subject discontinued shortly after randomization assignment.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race-Ethnicity', 'categories': [{'title': 'White-Caucasian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Black-African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race-Ethnicity based on Self-Description of participants. Other category involves participants with middle eastern or other background who could not give precise ethnic description.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'One subject randomized to placebo group discontinued participation before the first post-baseline measurement, and, therefore, eh was not considered as relevant in the analysis of data. Therefore, background data is presented on 39 of the 40 subjects who were analyzed for outcome variables.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-20', 'studyFirstSubmitDate': '2008-07-01', 'resultsFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2008-07-02', 'lastUpdatePostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-20', 'studyFirstPostDateStruct': {'date': '2008-07-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Weight', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period', 'description': 'Least Squares estimated change in weight from end of study minus baseline'}], 'secondaryOutcomes': [{'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in BMI from end of study minus baseline'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in waist circumference from end of study minus baseline'}, {'measure': 'Change in Hip Circumference', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in hip circumference from end of study minus baseline'}, {'measure': 'Change in Glucose', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in glucose from end of study minus baseline'}, {'measure': 'Change in Cholesterol', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in cholesterol from end of study minus baseline'}, {'measure': 'Change in LDL', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in LDL from end of study minus baseline'}, {'measure': 'Change in HDL', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in HDL from end of study minus baseline'}, {'measure': 'Change in Triglycerides', 'timeFrame': 'Measured at each visit from baseline to end of study over a 12 week period.', 'description': 'Least Squares estimated change in triglycerides from end of study minus baseline'}, {'measure': 'Change in Appetite Hunger', 'timeFrame': 'Measured at baseline and 12 weeks', 'description': 'Least Squares estimated change in appetite hunger from end of study minus baseline.The scale used has no specific name. It is a Visual Analogue Scale, where a line is drawn of 10 cm long with the statement beneath the line" How Hungry do you feel \'. The subject places an X on the line. The measurements, the number of centimeters from the start of the line ("O"), indicate the amount of hunger. The higher the cm number the higher the feeling of hunger. The measure reported is the difference in this scale reading in cm from after the test meal to before consuming the test meal. The number (mean, s.e.m) presented is the analysis of covariance model estimated difference score at the end of study, with the covariate of the same score at baseline.'}, {'measure': 'Change in Appetite Fullness', 'timeFrame': '.Measured at baseline and 12 weeks', 'description': 'Least Squares estimated change in appetite fullness from end of study minus baseline.The scale used has no specific name. It is a Visual Analogue Scale, where a line is drawn of 10 cm long with the statement beneath the line" How full do you feel \'. The subject places an X on the line. The measurements, the number of centimeters from the start of the line ("O"). indicate amount of feeling of fullness. The higher the cm number the higher the feeling of fullness. The measure reported is the difference in this scale reading in cm from after the test meal to before consuming the test meal. The number (mean, s.e.m.) presented is the analysis of covariance model estimated difference score at the end of study, with the covariate of the same score at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Schizophreniform Disorder', 'Bipolar I Disorder', 'Bipolar II', 'Bipolar NOS(Not Otherwise Specified)', 'Psychotic Disorder Not Otherwise Specified', 'Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '30542300', 'type': 'DERIVED', 'citation': 'Kang D, Jing Z, Li R, Hei G, Shao T, Li L, Sun M, Yang Y, Wang Y, Wang X, Long Y, Huang X, Wu R. Effect of Betahistine and Metformin on Antipsychotic-Induced Weight Gain: An Analysis of Two Clinical Trials. Front Psychiatry. 2018 Nov 27;9:620. doi: 10.3389/fpsyt.2018.00620. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': "The study attempts to evaluate a histamine analog long used for the treatment of Meniere's disease, betahistine, that shows promise in reversing the antihistaminergic effects thought to be involved in antipsychotic induced weight gain.\n\nHypothesis to be tested:\n\nA. Patients who have gained a developmentally inappropriate amount of weight on antipsychotics (AP) will see their weight and BMI decrease with betahistine augmentation as compared to placebo augmentation.\n\nB. Betahistine augmentation in AP treated patients will increase levels of satiety in a standardized meal situation and decrease caloric intake as compared to placebo augmentation.\n\nC. Metabolic effects of betahistine augmentation in AP treated patients will be reflected in differences in waist circumference, hip circumference and waist hip ratios D. Betahistine augmentation in this population will lead to decrease in fasting glucose-lipid lab values related to the development of metabolic syndrome as compared to placebo augmentation", 'detailedDescription': 'Subjects for this study were adolescents and adults from age 12 to age 59. Subjects were individuals who have been psychiatrically stabilized on first or second generation antipsychotic medication, and have gained substantial weight during their treatment. Subjects were excluded if they have asthma, peptic ulcer disease (diseases which may be exacerbated by a histamine analog) or are prescribed medications known to affect body composition or metabolism other than those currently being studied. Subjects were randomized to receive either betahistine or placebo at a 1:1 ratio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents and Adults ages 12-59 with a diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform, Bipolar I, Bipolar II, Bipolar NOS or Psychotic Disorder NOS, Autism Spectrum Disorder\n* Patients will be currently treated with antipsychotics\n\nPatients will qualify for entry if they meet the following weight criteria:\n\n1. The patient has gained 7% of their weight since beginning of treatment with one or more of the current antipsychotics.\n2. The patient has had an increase of 7% of their weight during the last year while being treated with antipsychotics.\n3. The patient has a BMI of 30 or more and has gained 10 lbs or more in the past 8 months while being treated with antipsychotic medications.\n4. The patient has a BMI of 35 or greater at the current time, and his chart shows a history of consistent weight gain over the past 1 to 3 years during treatment with antipsychotics.\n\n .\n\n Exclusion Criteria:\n * Subjects will be excluded if they have asthma, peptic ulcer disease (diseases which may be exacerbated by a histamine analog), or history of pheochromocytoma or peptic ulcer disease. Patients will be excluded if they are prescribed medications known to affect body weight or glucose-lipid metabolism, such as prescription or over the counter medications taken for the purpose of weight reduction. Subjects who are currently treated with metformin, for less than 6 months and have shown recent weight change on metformin. Patients on thyroid replacement therapy or lipid-lowering agents whose dosage has changed by more than 50 % in the past month will be excluded. If they are relatively stable doses of these medications they will not be excluded. Patients who are on lipid lowering medication, thyroid replacement medication, or diabetes medication, (excluding metformin), must remain on these medications throughout the period of the study. Females who are pregnant or breast feeding will be excluded.'}, 'identificationModule': {'nctId': 'NCT00709202', 'briefTitle': 'Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain', 'organization': {'class': 'OTHER', 'fullName': 'Nathan Kline Institute for Psychiatric Research'}, 'officialTitle': 'The Attenuation of Second Generation Antipsychotic Induced Weight Gain in Adolescents and Adults Using Betahistine: A Double-Blind, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '07TGF-1112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Subjects assigned to this arm will receive Betahistine.', 'interventionNames': ['Drug: Betahistine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Subjects in this group will received placebo.', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Betahistine', 'type': 'DRUG', 'otherNames': ['Serc, Betaserc, Betaserk'], 'description': 'Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID (BID = 2 times a day)..', 'armGroupLabels': ['1']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10962', 'city': 'Orangeburg', 'state': 'New York', 'country': 'United States', 'facility': 'Nathan Kline Insitute for Psychiatric Research', 'geoPoint': {'lat': 41.04649, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'Robert C Smith, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nathan Kline Institute for Psychiatric Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nathan Kline Institute for Psychiatric Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanley Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Psychiatrist, Research Professor of Psychiatry', 'investigatorFullName': 'Robert C. Smith MD PhD', 'investigatorAffiliation': 'Nathan Kline Institute for Psychiatric Research'}}}}