2010
Multicenter, randomized, double‐blind, active comparator and placebo‐controlled trial of a corticotropin‐releasing factor receptor‐1 antagonist in generalized anxiety disorder
Coric V, Feldman HH, Oren DA, Shekhar A, Pultz J, Dockens RC, Wu X, Gentile KA, Huang S, Emison E, Delmonte T, D'Souza BB, Zimbroff DL, Grebb JA, Goddard AW, Stock EG. Multicenter, randomized, double‐blind, active comparator and placebo‐controlled trial of a corticotropin‐releasing factor receptor‐1 antagonist in generalized anxiety disorder. Depression And Anxiety 2010, 27: 417-425. PMID: 20455246, DOI: 10.1002/da.20695.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAnti-Anxiety AgentsAnxiety DisordersCitalopramDiagnostic and Statistical Manual of Mental DisordersDouble-Blind MethodFemaleHumansMaleMiddle AgedPharmacogeneticsPhenotypePolymorphism, Single NucleotidePsychometricsPyrazolesReceptors, Corticotropin-Releasing HormoneSeverity of Illness IndexTriazinesYoung AdultConceptsGeneralized anxiety disorderSingle nucleotide polymorphismsHamilton Anxiety Scale (HAMA) total scoreAnxiety disordersFactor receptor 1 antagonistActive comparator armCorticotropin-releasing factor receptorsActive comparator trialsPlacebo-controlled trialCorticotropin-releasing factor receptor 1 antagonistTreatment of GADPrimary outcome measurePlexin-A2Receptor 1 antagonistScale total scoreCRF-1 receptor antagonistClass of agentsComparator trialsComparator armPrimary outcomeActive comparatorEntire cohortRandomized subjectsReceptor antagonistMean change
2007
Efficacy and Safety of Oral Aripiprazole Compared with Haloperidol in Patients Transitioning from Acute Treatment with Intramuscular Formulations
DANIEL D, CURRIER G, ZIMBROFF D, ALLEN M, OREN D, MANOS G, MCQUADE R, PIKALOV A, CRANDALL D. Efficacy and Safety of Oral Aripiprazole Compared with Haloperidol in Patients Transitioning from Acute Treatment with Intramuscular Formulations. Journal Of Psychiatric Practice 2007, 13: 170-177. PMID: 17522560, DOI: 10.1097/01.pra.0000271658.86845.81.Peer-Reviewed Original ResearchMeSH KeywordsAcute DiseaseAdministration, OralAdolescentAdultAgedAntipsychotic AgentsAripiprazoleDouble-Blind MethodDyskinesia, Drug-InducedFemaleHaloperidolHumansInjections, IntramuscularMaleMiddle AgedPiperazinesPsychiatric Status Rating ScalesPsychomotor AgitationPsychotic DisordersQuinolonesSchizophreniaConceptsOral aripiprazoleOral formulationHaloperidol IMOral phaseIntramuscular formulationEfficacy measuresSchizoaffective disorderExtrapyramidal symptom-related adverse eventsPrimary efficacy measureStudy days 1Negative Syndrome ScalePlacebo IMAcute treatmentAdverse eventsGood tolerabilityClinical statusMean changePEC scoresPatientsDay 1HaloperidolAripiprazoleSyndrome ScaleInitial benefitComponent scoresIntramuscular Aripiprazole in the Control of Agitation
CURRIER G, CITROME L, ZIMBROFF D, OREN D, MANOS G, MCQUADE R, PIKALOV A, CRANDALL D. Intramuscular Aripiprazole in the Control of Agitation. Journal Of Psychiatric Practice 2007, 13: 159-169. PMID: 17522559, DOI: 10.1097/01.pra.0000271657.09717.e2.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntipsychotic AgentsAripiprazoleArousalBipolar DisorderDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHaloperidolHumansHypnotics and SedativesInjections, IntramuscularLorazepamMaleMiddle AgedMulticenter Studies as TopicPiperazinesPsychiatric Status Rating ScalesPsychomotor AgitationQuinolonesRandomized Controlled Trials as TopicSchizophreniaSchizophrenic PsychologyTreatment OutcomeConceptsBipolar I disorderPEC scoresAripiprazole injectionI disordersBaseline agitationSecond injectionNegative Syndrome Scale Excited ComponentBaseline levelsSecondary analysisControl of agitationImportant clinical issueIntramuscular aripiprazoleAnalysis 3Clinical trialsAgitation symptomsMean changeNonspecific sedationPatientsBaseline scoresClinical issuesPlaceboAnalysis 2Analysis 1Study periodSchizophreniaManagement of Acute Agitation in Patients With Bipolar Disorder
Zimbroff D, Marcus R, Manos G, Stock E, McQuade R, Auby P, Oren D. Management of Acute Agitation in Patients With Bipolar Disorder. Journal Of Clinical Psychopharmacology 2007, 27: 171-176. PMID: 17414241, DOI: 10.1097/jcp.0b13e318033bd5e.Peer-Reviewed Original ResearchMeSH KeywordsAcute DiseaseAdultAnti-Anxiety AgentsAntipsychotic AgentsAripiprazoleBipolar DisorderDisorders of Excessive SomnolenceDizzinessDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHeadacheHumansInjections, IntramuscularLorazepamMaleNauseaPatient DropoutsPiperazinesPsychomotor AgitationQuinolonesSleep Initiation and Maintenance DisordersTreatment OutcomeVomitingConceptsIM aripiprazoleIM placeboIM lorazepamAcute agitationActive treatmentEfficacy measuresFirst injectionBipolar disorderDouble-blind multicenter studyTreatment of agitationPrimary efficacy measureRisk-benefit profileComponent scoresAripiprazole dosesIntramuscular aripiprazoleOral aripiprazoleMixed episodesMulticenter studySafety profileEfficacy parametersLower incidenceMean changePlaceboAripiprazolePatientsEfficacy and safety of intramuscular aripiprazole in patients with acute agitation: a randomized, double-blind, placebo-controlled trial.
Tran-Johnson T, Sack D, Marcus R, Auby P, McQuade R, Oren D. Efficacy and safety of intramuscular aripiprazole in patients with acute agitation: a randomized, double-blind, placebo-controlled trial. The Journal Of Clinical Psychiatry 2007, 68: 111-9. PMID: 17284138, DOI: 10.4088/jcp.v68n0115.Peer-Reviewed Original ResearchConceptsPrimary efficacy measureIntramuscular aripiprazoleIM haloperidolIM aripiprazoleAcute agitationAdverse eventsEfficacy measuresTreatment-emergent adverse eventsCommon adverse eventsPlacebo-controlled trialPlacebo-controlled studyControl of agitationSchizo-affective disorderDSM-IV diagnosisNegative Syndrome ScaleHaloperidol groupIntramuscular haloperidolExtrapyramidal symptomsMore patientsInitial dosingSchizophreniform disorderMean changePlaceboSecondary measuresPEC scores
2006
Intramuscular aripiprazole or haloperidol and transition to oral therapy in patients with agitation associated with schizophrenia: sub-analysis of a double-blind study*
Andrezina R, Marcus R, Oren D, Manos G, Stock E, Carson W, McQuade R. Intramuscular aripiprazole or haloperidol and transition to oral therapy in patients with agitation associated with schizophrenia: sub-analysis of a double-blind study*. Current Medical Research And Opinion 2006, 22: 2209-2219. PMID: 17076982, DOI: 10.1185/030079906x148445.Peer-Reviewed Original ResearchConceptsDouble-blind studyIM haloperidolIM placeboIntramuscular aripiprazoleIM aripiprazoleOral aripiprazoleOral therapyEfficacy measuresIM treatmentPEC scoresExtrapyramidal symptom-related adverse eventsSecondary efficacy measuresPrimary efficacy measureAripiprazole therapyAcute agitationAdverse eventsOral treatmentActive treatmentSafety profileIM injectionMean changeMean improvementPlaceboHaloperidolAripiprazoleIntramuscular aripiprazole for the treatment of acute agitation in patients with schizophrenia or schizoaffective disorder: a double-blind, placebo-controlled comparison with intramuscular haloperidol
Andrezina R, Josiassen R, Marcus R, Oren D, Manos G, Stock E, Carson W, Iwamoto T. Intramuscular aripiprazole for the treatment of acute agitation in patients with schizophrenia or schizoaffective disorder: a double-blind, placebo-controlled comparison with intramuscular haloperidol. Psychopharmacology 2006, 188: 281-292. PMID: 16953381, DOI: 10.1007/s00213-006-0541-x.Peer-Reviewed Original ResearchMeSH KeywordsAcute DiseaseAdministration, OralAdolescentAdultAnti-Dyskinesia AgentsAntipsychotic AgentsAripiprazoleBasal Ganglia DiseasesBenzodiazepinesBlood GlucoseDouble-Blind MethodDrug Therapy, CombinationFemaleHaloperidolHumansInjections, IntramuscularMalePiperazinesPsychomotor AgitationPsychotic DisordersQuinolonesSchizophreniaTime FactorsTreatment OutcomeWithholding TreatmentConceptsIM aripiprazoleIM haloperidolAcute agitationIntramuscular aripiprazoleEfficacy measuresSchizoaffective disorderExtrapyramidal symptom-related adverse eventsPlacebo-controlled studySecondary efficacy measuresPercentage of patientsPlacebo-controlled comparisonPrimary efficacy measureIM placeboIntramuscular haloperidolAdverse eventsMethodsFour hundredThird injectionMean changePlaceboEffective treatmentHaloperidolPatientsAripiprazoleConclusionThese resultsMean number