2023
P105: Measuring clinically relevant change in apathy symptoms in ADMET 2
Tuma S, Herrmann N, Perin J, Rosenberg P, Lerner A, Padala P, Brawman-Mintzer O, van Dyck C, Porsteinsson A, CraG S, Levey A, Shade D, Mintzer J, Lanctôt K. P105: Measuring clinically relevant change in apathy symptoms in ADMET 2. International Psychogeriatrics 2023, 35: 126-127. DOI: 10.1017/s1041610223002569.Peer-Reviewed Original ResearchImpression of ChangeChange scoresMeasure clinically relevant changesNPI apathy scoreEffect sizeClinical impression of changeMinimal clinically significant improvementClinical Global Impression of ChangeSpearman correlationClinical Global ImpressionClinically significant improvementSix-month visitGlobal Impression of ChangePsychosocial interventionsClinically relevant changesApathy symptomsAssessment ScaleAssessment Change ScoreMann-Whitney U testComplete dataWorsened groupParticipantsApathyNo changeTreatment trials
2021
Apathy in Dementia Methylphenidate Trial 2 (ADMET2): Results of a phase III, placebo‐controlled, double‐blind, 6‐month, multi‐center, randomized clinical trial
Mintzer J, Scherer R, Drye L, Lanctôt K, Rosenberg P, Herrmann N, Padala P, Brawman‐Mintzer O, Lerner A, Levey A, Porsteinsson A, van Dyck C. Apathy in Dementia Methylphenidate Trial 2 (ADMET2): Results of a phase III, placebo‐controlled, double‐blind, 6‐month, multi‐center, randomized clinical trial. Alzheimer's & Dementia 2021, 17 DOI: 10.1002/alz.051489.Peer-Reviewed Original ResearchAlzheimer's diseasePlacebo groupMethylphenidate groupClinical trialsAD Cooperative Study-Clinical Global ImpressionPhase IIITreatment of apathyClinical Global ImpressionRatings of improvementADCS-CGICAdverse eventsSecondary outcomesMonth 6Primary outcomeNeuropsychiatric symptomsSafety profileGlobal ImpressionSmall studyViable treatmentStudy participantsMean differenceMonthsMethylphenidatePrevious trialsTrialsEfficacy and safety of transcranial direct current stimulation as an add-on treatment for obsessive-compulsive disorder: a randomized, sham-controlled trial
Silva R, Brunoni A, Goerigk S, Batistuzzo M, Costa D, Diniz J, Padberg F, D’Urso G, Miguel E, Shavitt R. Efficacy and safety of transcranial direct current stimulation as an add-on treatment for obsessive-compulsive disorder: a randomized, sham-controlled trial. Neuropsychopharmacology 2021, 46: 1028-1034. PMID: 33452434, PMCID: PMC8115679, DOI: 10.1038/s41386-020-00928-w.Peer-Reviewed Original ResearchConceptsTreatment-resistant obsessive-compulsive disorderTranscranial direct current stimulationSupplementary motor areaBaseline Y-BOCS scoresActive transcranial direct current stimulationObsessive-compulsive disorderY-BOCS scoresDirect current stimulationAdverse eventsWeek 12Efficacy of tDCSCurrent stimulationCathodal transcranial direct current stimulationSham-controlled trialMild adverse eventsClinical Global ImpressionSham-controlled studyBetween-group differencesSymptoms of depressionSecondary outcomesPrimary outcomeImprovement subscaleGlobal ImpressionNeuromodulation therapiesTreatment resistance
2020
170 Efficacy and Safety of Dasotraline in Adults with Binge-Eating Disorder: A Randomized, Double-blind, Fixed-dose Trial
Tsai J, Navia B, McElroy S, Hudson J, Grilo C, Goldman R, Deng L, Kent J, Loebel A. 170 Efficacy and Safety of Dasotraline in Adults with Binge-Eating Disorder: A Randomized, Double-blind, Fixed-dose Trial. CNS Spectrums 2020, 25: 308-309. DOI: 10.1017/s1092852920000863.Peer-Reviewed Original ResearchBinge-eating disorderEfficacy endpointWeek 12Dopamine/norepinephrine reuptake inhibitorFlexible-dose studySafety of dasotralineDouble-blind treatmentFixed-dose studyPrimary efficacy endpointProportion of patientsSecondary efficacy endpointsClinical Global ImpressionNorepinephrine reuptake inhibitorsWeeks of treatmentTreatment of patientsCompulsive Scale ModifiedBinge-eating episodesDSM-5 criteriaYale-Brown ObsessiveITT populationReuptake inhibitorsGlobal ImpressionDose studySignificant efficacySeverity ScalePatient Preference and Improved Clinical Global Impression of Change with Rimegepant for the Acute Treatment of Migraine: Results from a Long-Term Open-Label Safety Study (Study 201) (2112)
Jensen C, Croop R, Lipton R, Stock E, Thiry A, Conway C, Lovegren M, Coric V, L’Italien G. Patient Preference and Improved Clinical Global Impression of Change with Rimegepant for the Acute Treatment of Migraine: Results from a Long-Term Open-Label Safety Study (Study 201) (2112). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.2112.Peer-Reviewed Original Research
2019
Kundalini Yoga Meditation Versus the Relaxation Response Meditation for Treating Adults With Obsessive-Compulsive Disorder: A Randomized Clinical Trial
Shannahoff-Khalsa D, Fernandes RY, de B. Pereira C, March JS, Leckman JF, Golshan S, Vieira MSR, Polanczyk GV, Miguel EC, Shavitt RG. Kundalini Yoga Meditation Versus the Relaxation Response Meditation for Treating Adults With Obsessive-Compulsive Disorder: A Randomized Clinical Trial. Frontiers In Psychiatry 2019, 10: 793. PMID: 31780963, PMCID: PMC6859828, DOI: 10.3389/fpsyt.2019.00793.Peer-Reviewed Original ResearchY-BOCS scoresFirst-line therapyObsessive-compulsive disorderClinical trialsSecondary measuresY-BOCSShort Form-36 Health SurveyBaseline Y-BOCS scoresCompulsive ScaleGreater improvementRelative efficacyClinical Global ImpressionEffective treatment scheduleYale-Brown Obsessive Compulsive ScaleHigh psychosocial impairmentBeck Depression InventoryBeck Anxiety InventoryLife-long disorderObsessive Compulsive ScaleYale-Brown ObsessiveYoga meditationLine therapyPrimary outcomeTreat analysisReuptake inhibitors
2016
Arbaclofen in Children and Adolescents with Autism Spectrum Disorder: A Randomized, Controlled, Phase 2 Trial
Veenstra-VanderWeele J, Cook E, King B, Zarevics P, Cherubini M, Walton-Bowen K, Bear M, Wang P, Carpenter R. Arbaclofen in Children and Adolescents with Autism Spectrum Disorder: A Randomized, Controlled, Phase 2 Trial. Neuropsychopharmacology 2016, 42: 1390-1398. PMID: 27748740, PMCID: PMC5436109, DOI: 10.1038/npp.2016.237.Peer-Reviewed Original ResearchConceptsAutism spectrum disorderFragile X syndromeSpectrum disorderClinician-rated Clinical Global ImpressionAnimal models of fragile X syndromeGABA-BModel of fragile X syndromeSocial avoidance symptomsClinical Global ImpressionPlacebo-ControlledGABA-B agonistSubgroups of individualsPilot open-label trialExploratory post hoc analysisAffective labilityAvoidance symptomsPost hoc analysis of participantsOpen-label trialBehavioral phenotypesGlobal ImpressionArbaclofenSecondary analysisX syndromeSocial behaviorSocial domainsThe Pharmacogenomics of Bipolar Disorder study (PGBD): identification of genes for lithium response in a prospective sample
Oedegaard K, Alda M, Anand A, Andreassen O, Balaraman Y, Berrettini W, Bhattacharjee A, Brennand K, Burdick K, Calabrese J, Calkin C, Claasen A, Coryell W, Craig D, DeModena A, Frye M, Gage F, Gao K, Garnham J, Gershon E, Jakobsen P, Leckband S, McCarthy M, McInnis M, Maihofer A, Mertens J, Morken G, Nievergelt C, Nurnberger J, Pham S, Schoeyen H, Shekhtman T, Shilling P, Szelinger S, Tarwater B, Yao J, Zandi P, Kelsoe J. The Pharmacogenomics of Bipolar Disorder study (PGBD): identification of genes for lithium response in a prospective sample. BMC Psychiatry 2016, 16: 129. PMID: 27150464, PMCID: PMC4857276, DOI: 10.1186/s12888-016-0732-x.Peer-Reviewed Original ResearchConceptsLithium monotherapyBipolar disorderLithium responseMechanism of actionClinical managementValproic acidLithium respondersSingle nucleotide polymorphismsMethods/designThis studyCox proportional hazards modelProspective study sampleLarge prospective cohortLarge prospective studiesClinical Global ImpressionInitiation of treatmentMood-stabilizing medicationsBipolar Disorder (STEP-BD) studyProportional hazards modelResults of treatmentCommon psychiatric disordersMEq/L.Genome-wide association studiesClinical relapseProspective cohortRemitting course
2015
Effect of Parent Training vs Parent Education on Behavioral Problems in Children With Autism Spectrum Disorder: A Randomized Clinical Trial
Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, McAdam DB, Butter E, Stillitano C, Minshawi N, Sukhodolsky DG, Mruzek DW, Turner K, Neal T, Hallett V, Mulick JA, Green B, Handen B, Deng Y, Dziura J, Scahill L. Effect of Parent Training vs Parent Education on Behavioral Problems in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA 2015, 313: 1524-1533. PMID: 25898050, PMCID: PMC9078140, DOI: 10.1001/jama.2015.3150.Peer-Reviewed Original ResearchConceptsAberrant Behavior Checklist-Irritability subscaleClinical Global Impressions-Improvement scaleParent trainingCo-primary outcomesAutism spectrum disorderClinical Global ImpressionSpectrum disorderDisruptive behaviorParent-reported outcomesParent educationPositive responseClinical improvementSecondary outcomesWeek 24Global ImpressionBlinded cliniciansClinical trialsClinical significanceMAIN OUTCOMEImprovement ScaleGreater severityTreatment assignment
2013
Health‐related quality of life and symptom severity in Chinese patients with major depressive disorder
Cao Y, Li W, Shen J, Malison RT, Zhang Y, Luo X. Health‐related quality of life and symptom severity in Chinese patients with major depressive disorder. Asia-Pacific Psychiatry 2013, 5: 276-283. PMID: 23857826, DOI: 10.1111/appy.12059.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAntidepressive AgentsAnxietyAsian PeopleChinaDepressive Disorder, MajorFemaleFluoxetineHealth StatusHumansMaleMiddle AgedOutcome Assessment, Health CarePsychiatric Status Rating ScalesQuality of LifeSeverity of Illness IndexSomatoform DisordersSurveys and QuestionnairesYoung AdultConceptsMajor depressive disorderAnxiety/somatizationSF-36 scoresClinical Global ImpressionDepressive symptom severity
2009
Obsessive-compulsive symptoms and disorder in patients with schizophrenia treated with clozapine or haloperidol
R. A, Hounie A, Sampaio A, Arrais J, Miguel E, Elkis H. Obsessive-compulsive symptoms and disorder in patients with schizophrenia treated with clozapine or haloperidol. Comprehensive Psychiatry 2009, 50: 437-442. PMID: 19683614, DOI: 10.1016/j.comppsych.2008.11.005.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntidepressive AgentsAntipsychotic AgentsClozapineComorbidityDiagnostic and Statistical Manual of Mental DisordersDrug Therapy, CombinationFemaleHaloperidolHumansInterview, PsychologicalMaleMiddle AgedObsessive-Compulsive DisorderPsychiatric Status Rating ScalesPsychometricsSchizophreniaYoung AdultConceptsObsessive-compulsive disorderObsessive-compulsive symptomsSchizophrenia patientsPrevalence of OCDSchizophrenia rating scalesPresence of OCSPrevalence of patientsUse of clozapineUse of antidepressantsClinical Global ImpressionPANSS total scoreCross-sectional studyStructured Clinical InterviewHigher severity scoresNegative Syndrome ScaleHigher severityYale-Brown ObsessiveGlobal ImpressionSeverity scorePatientsClozapineClinical InterviewHaloperidolSchizophrenia symptomsSyndrome Scale
2007
Lamotrigine as Add-On Therapy in Schizophrenia
Goff DC, Keefe R, Citrome L, Davy K, Krystal JH, Large C, Thompson TR, Volavka J, Webster EL. Lamotrigine as Add-On Therapy in Schizophrenia. Journal Of Clinical Psychopharmacology 2007, 27: 582-589. PMID: 18004124, DOI: 10.1097/jcp.0b013e31815abf34.Peer-Reviewed Original ResearchMeSH KeywordsAdultAnticonvulsantsAntipsychotic AgentsClozapineDiagnostic and Statistical Manual of Mental DisordersDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug ResistanceDrug Therapy, CombinationFemaleHumansLamotrigineMaleMiddle AgedPatient CompliancePatient DropoutsPsychiatric Status Rating ScalesSchizophreniaSeverity of Illness IndexSuicide, AttemptedTreatment OutcomeTriazinesConceptsNegative Syndrome Scale total scoreScale total scoreAntipsychotic medicationTotal scoreTreatment groupsSchizophrenia patientsPlacebo-controlled trialPrimary end pointParallel-group trialUse of lamotrigineClinical Global ImpressionAtypical antipsychotic medicationsResidual psychotic symptomsSymptom total scoreNegative Symptoms total scoreLamotrigine augmentationLamotrigine trialsRefractory psychosisAtypical antipsychoticsCognitive composite scoreWeek 12Global ImpressionTreat samplePsychotic symptomsLamotrigineA Randomized, Double-Blind, Placebo-Controlled Clinical Trial on Once-Daily Atomoxetine Hydrochloride in Taiwanese Children and Adolescents with Attention-Deficit/Hyperactivity Disorder
Gau SS, Huang YS, Soong WT, Chou MC, Chou WJ, Shang CY, Tseng WL, Allen AJ, Lee P. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial on Once-Daily Atomoxetine Hydrochloride in Taiwanese Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. Journal Of Child And Adolescent Psychopharmacology 2007, 17: 447-460. PMID: 17822340, DOI: 10.1089/cap.2006.0091.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdrenergic Uptake InhibitorsAppetiteAtomoxetine HydrochlorideAttention Deficit Disorder with HyperactivityChildDouble-Blind MethodDrug Administration ScheduleFacultyFemaleHumansMaleNauseaParentsPropylaminesPsychiatric Status Rating ScalesSeverity of Illness IndexTaiwanTreatment OutcomeConceptsAttention-deficit/hyperactivity disorderPrimary efficacy measureEfficacy measuresDaily atomoxetineAdverse eventsADHD Rating Scale-IV-Parent VersionDrug-related serious adverse eventsHyperactivity disorderSecondary efficacy measuresSerious adverse eventsClinical Global ImpressionCarried-forward approachEnd of studyTreatment effect sizeAtomoxetine groupPlacebo groupTreat basisPediatric patientsGlobal ImpressionSafe treatmentClinical trialsInvestigator AdministeredEdition criteriaTreatment groupsMental disorders
2006
Randomized Trial of Parent Management Training in Children With Tic Disorders and Disruptive Behavior
Scahill L, Sukhodolsky DG, Bearss K, Findley D, Hamrin V, Carroll DH, Rains AL. Randomized Trial of Parent Management Training in Children With Tic Disorders and Disruptive Behavior. Journal Of Child Neurology 2006, 21: 650-656. PMID: 16970865, DOI: 10.1177/08830738060210080201.Peer-Reviewed Original ResearchConceptsTic disordersParent management trainingUsual groupClinical Global ImpressionShort-term efficacyRating Scale scoresShort-term improvementDisruptive behaviorRandomized trialsStable medicationBehavior rating scale scoresGlobal ImpressionParent management training programsClinical trialsImprovement ScaleScale scoreStructured parent training programTraining programTreatment assignmentParent training programTraining groupDisruptive behavior problemsDisordersClinical samplesSevere levelsInterrater reliability and clinical efficacy of Children's Yale-Brown Obsessive-Compulsive Scale in an outpatient setting
Yucelen A, Rodopman-Arman A, Topcuoglu V, Yazgan M, Fisek G. Interrater reliability and clinical efficacy of Children's Yale-Brown Obsessive-Compulsive Scale in an outpatient setting. Comprehensive Psychiatry 2006, 47: 48-53. PMID: 16324902, DOI: 10.1016/j.comppsych.2005.04.005.Peer-Reviewed Original ResearchConceptsObsessive-compulsive disorderChildren's Yale-Brown ObsessiveCY-BOCS total scoreYale-Brown ObsessiveCY-BOCSChildren's Depression InventoryDepression InventoryClinical efficacyCompulsive ScaleChild Behavior Checklist scoresChild Behavior ChecklistOutpatient settingCY-BOCS scoresImpression ScaleInterrater reliabilityClinical Global Impression scoresTotal scoreChild versionLeyton Obsessional InventoryTurkish versionBehavior ChecklistClinical outpatient settingClinical Global ImpressionCorrelational analysisGlobal Impression Scale
2000
Estrogen Replacement Therapy for Treatment of Mild to Moderate Alzheimer Disease: A Randomized Controlled Trial
Mulnard R, Cotman C, Kawas C, van Dyck C, Sano M, Doody R, Koss E, Pfeiffer E, Jin S, Gamst A, Grundman M, Thomas R, Study L. Estrogen Replacement Therapy for Treatment of Mild to Moderate Alzheimer Disease: A Randomized Controlled Trial. Obstetrical & Gynecological Survey 2000, 55: 439-440. DOI: 10.1097/00006254-200007000-00021.Peer-Reviewed Original ResearchMini-Mental State ExaminationCognitive functionAlzheimer's diseaseMultiple Affect Adjective ChecklistMeasures of moodMMSE scoresSingle-blind placebo washout phaseVerbal learningLanguage measuresClinical Dementia Rating ScaleCategory fluencyPlacebo washout phaseDouble-blind trialLow-dose estrogenConjugated equine estrogensEstrogen replacement therapyDementia Rating ScaleTreatment of mildClinical Global ImpressionPrimary outcome measureHamilton Depression ScaleAdjective ChecklistModerate Alzheimer's diseaseOnset of diseaseGlobal functioningAssessment in Multisite Randomized Clinical Trials of Patients with Autistic Disorder: The Autism RUPP Network
Arnold L, Aman M, Martin A, Collier-Crespin A, Vitiello B, Tierney E, Asarnow R, Bell-Bradshaw F, Freeman B, Gates-Ulanet P, Klin A, McCracken J, McDougle C, McGough J, Posey D, Scahill L, Swiezy N, Ritz L, Vokmar F. Assessment in Multisite Randomized Clinical Trials of Patients with Autistic Disorder: The Autism RUPP Network. Journal Of Autism And Developmental Disorders 2000, 30: 99-111. PMID: 10832774, DOI: 10.1023/a:1005451304303.Peer-Reviewed Original ResearchConceptsAutism Diagnostic InterviewChildren/adolescentsAutistic disorders symptomsNeuropsychological testsDisorder symptomsLower functioningAutistic disorderCore featuresTest developersDiagnostic InterviewProblem presentationPediatric psychopharmacologyAutismIndividual changesTreatment respondersTarget symptomsSecondary symptomsCommunication problemsMethodological challengesAssessment strategiesSubject heterogeneityIQPharmacological treatmentDisordersClinical Global ImpressionEstrogen Replacement Therapy for Treatment of Mild to Moderate Alzheimer Disease: A Randomized Controlled Trial
Mulnard R, Cotman C, Kawas C, van Dyck C, Sano M, Doody R, Koss E, Pfeiffer E, Jin S, Gamst A, Grundman M, Thomas R, Thal L, Study F. Estrogen Replacement Therapy for Treatment of Mild to Moderate Alzheimer Disease: A Randomized Controlled Trial. JAMA 2000, 283: 1007-1015. PMID: 10697060, DOI: 10.1001/jama.283.8.1007.Peer-Reviewed Original ResearchConceptsEstrogen replacement therapyModerate Alzheimer's diseaseSecondary outcome measuresReplacement therapyAlzheimer's diseaseOutcome measuresClinical trialsPlacebo-controlled clinical trialMini-Mental State Examination scoreAlzheimer's Disease Cooperative StudyPrevention of ADClinical Dementia Rating ScaleClinical Global ImpressionPrimary outcome measureTreatment of mildSmall clinical trialsRole of estrogenState Examination scoreDementia Rating ScaleCGIC scoresEstrogen groupPlacebo groupControlled TrialsFunctional outcomeGlobal Impression
1997
Performance of the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) in multicenter clinical trials
Cedarbaum J, Stambler N. Performance of the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) in multicenter clinical trials. Journal Of The Neurological Sciences 1997, 152: s1-s9. PMID: 9419047, DOI: 10.1016/s0022-510x(97)00237-2.Peer-Reviewed Original ResearchConceptsAmyotrophic Lateral Sclerosis Functional Rating ScaleFunctional Rating ScaleMulticenter clinical trialFunctional statusRating ScaleClinical trialsPatients' functional statusClinical Global ImpressionMuscle strength testingArea of feedingPlacebo patientsTherapeutic trialsTest-retest reliabilityGlobal ImpressionPatient levelTreatment studiesChange ScaleTrialsPatientsMaximum scoreIndependent assessmentStrength testingAmbulation
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