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
2009
Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study
Young A, Oren D, Lowy A, McQuade R, Marcus R, Carson W, Spiller N, Torbeyns A, Sanchez R. Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study. The British Journal Of Psychiatry 2009, 194: 40-48. PMID: 19118324, DOI: 10.1192/bjp.bp.108.049965.Peer-Reviewed Original ResearchConceptsWeek 12Young Mania Rating Scale (YMRS) total scoreDouble-blind aripiprazoleHaloperidol-treated patientsTolerability of aripiprazoleExtrapyramidal adverse eventsScale total scoreMasked treatmentAdverse eventsClinical improvementAcute maniaAripiprazole monotherapyBipolar maniaMixed episodesEffective therapyEffect therapyAripiprazoleAdditional weeksHaloperidolWeek 3PlaceboPatientsTotal scoreTherapyMania
2008
A Randomized, Double-Blind, Placebo-Controlled Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients With Alzheimer's, Vascular, or Mixed Dementia
Rappaport S, Marcus R, Manos G, McQuade R, Oren D. A Randomized, Double-Blind, Placebo-Controlled Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients With Alzheimer's, Vascular, or Mixed Dementia. Journal Of The American Medical Directors Association 2008, 10: 21-27. PMID: 19111849, DOI: 10.1016/j.jamda.2008.06.006.Peer-Reviewed Original ResearchConceptsAgitation-Calmness Evaluation ScaleIM aripiprazoleIM placeboMixed dementiaIntramuscular aripiprazoleDoses 2 hoursIncidence of oversedationTreatment of agitationHealthcare facilitiesPreliminary efficacy analysisAdverse event reportingNegative Syndrome ScaleLong-term careAcute agitationEfficacy analysisTolerability studyPlaceboPEC scoresAripiprazoleGreater incidenceSyndrome ScaleGreater efficacyPatientsVital signsDementia
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
2004
Addition of the α2-Antagonist Yohimbine to Fluoxetine: Effects on Rate of Antidepressant Response
Sanacora G, Berman RM, Cappiello A, Oren DA, Kugaya A, Liu N, Gueorguieva R, Fasula D, Charney DS. Addition of the α2-Antagonist Yohimbine to Fluoxetine: Effects on Rate of Antidepressant Response. Neuropsychopharmacology 2004, 29: 1166-1171. PMID: 15010697, DOI: 10.1038/sj.npp.1300418.Peer-Reviewed Original ResearchConceptsHamilton depression scale ratingsΑ2-antagonist yohimbineAntidepressant responseClinical Global Impression ratingsBlood pressure changesPercentage of respondersLog-rank testGlobal Impression ratingsMajor depressive disorderMore rapid onsetP subjectsDSM-IV diagnosisSSRI agentsTitrated doseYohimbine doseAntidepressant actionAntidepressant medicationCGI scaleNoradrenergic toneMonoaminergic neurotransmissionΑ2-adrenoceptorsDepressive disorderTreatment periodOutcome measuresSCID interview
2003
Regional Brain Metabolic Correlates of α-Methylparatyrosine–Induced Depressive Symptoms: Implications for the Neural Circuitry of Depression
Bremner JD, Vythilingam M, Ng CK, Vermetten E, Nazeer A, Oren DA, Berman RM, Charney DS. Regional Brain Metabolic Correlates of α-Methylparatyrosine–Induced Depressive Symptoms: Implications for the Neural Circuitry of Depression. JAMA 2003, 289: 3125-3134. PMID: 12813118, PMCID: PMC3233764, DOI: 10.1001/jama.289.23.3125.Peer-Reviewed Original ResearchConceptsNorepinephrine reuptake inhibitorsSelective serotonin reuptake inhibitorsBrain metabolic correlatesDepressive symptomsDorsolateral prefrontal cortexReuptake inhibitorsBrain metabolismMetabolic correlatesPrefrontal cortexPsychiatric research unitDouble-blind trialPositron emission tomography (PET) measurementsDepletion of norepinephrineSerotonin reuptake inhibitorsDifferent neurochemical systemsCommon brain circuitryAMPT administrationInitial medicationPlacebo administrationLimbic areasAcute decreaseDepressed patientsCortical areasPatientsDay 3
2002
Lack of a therapeutic effect of a 2-week sub-threshold transcranial magnetic stimulation course for treatment-resistant depression
Boutros NN, Gueorguieva R, Hoffman RE, Oren DA, Feingold A, Berman RM. Lack of a therapeutic effect of a 2-week sub-threshold transcranial magnetic stimulation course for treatment-resistant depression. Psychiatry Research 2002, 113: 245-254. PMID: 12559481, DOI: 10.1016/s0165-1781(02)00267-6.Peer-Reviewed Original ResearchConceptsRepetitive transcranial magnetic stimulationTreatment-resistant depressed patientsDepressed patientsTherapeutic effectActive repetitive transcranial magnetic stimulationStimulation parametersTreatment-resistant depressionDouble-blind designTranscranial magnetic stimulationLeft prefrontal cortexSham groupMagnetic stimulationStimulation courseRTMS stimulationPatientsSystematic followThreshold stimulationPrefrontal cortexFollowPre-set criteriaSignificant differencesStimulationWork daysWeeksConsecutive work daysMonoamine depletion in unmedicated depressed subjects
Berman RM, Sanacora G, Anand A, Roach LM, Fasula MK, Finkelstein CO, Wachen RM, Oren DA, Heninger GR, Charney DS. Monoamine depletion in unmedicated depressed subjects. Biological Psychiatry 2002, 51: 469-473. PMID: 11922881, DOI: 10.1016/s0006-3223(01)01285-9.Peer-Reviewed Original ResearchConceptsUnmedicated depressed subjectsDepressed subjectsCatecholamine depletionDepressed patientsMean Hamilton Depression Rating Scale scoreHamilton Depression Rating Scale scoresRandom-order crossover studyDepression Rating Scale scoresRating Scale scoresDepressed control subjectsSignificant mood changesMonoamine depletionCrossover studyCatecholamine functionControl subjectsMonoamine functionMonoamine systemsStudy daysClinical depressionScale scoreMood changesPatientsIndoleamineGreater increaseIndirect mechanisms
2000
Attenuation of the Neuropsychiatric Effects of Ketamine With Lamotrigine: Support for Hyperglutamatergic Effects of N-methyl-D-aspartate Receptor Antagonists
Anand A, Charney DS, Oren DA, Berman RM, Hu XS, Cappiello A, Krystal JH. Attenuation of the Neuropsychiatric Effects of Ketamine With Lamotrigine: Support for Hyperglutamatergic Effects of N-methyl-D-aspartate Receptor Antagonists. JAMA Psychiatry 2000, 57: 270-276. PMID: 10711913, DOI: 10.1001/archpsyc.57.3.270.Peer-Reviewed Original ResearchMeSH KeywordsAdultAffectBrief Psychiatric Rating ScaleCognition DisordersDouble-Blind MethodExcitatory Amino Acid AntagonistsFemaleGlutamatesHumansKetamineLamotrigineMaleMental DisordersPerceptual DisordersPlacebosPsychiatric Status Rating ScalesReceptors, N-Methyl-D-AspartateSchizophreniaSchizophrenic PsychologyTriazinesVerbal LearningConceptsN-methyl-D-aspartate receptor antagonistNMDA receptor dysfunctionReceptor antagonistNeuropsychiatric effectsGlutamate releaseReceptor dysfunctionSymptom subscalesPlacebo 2 hoursClinician-Administered Dissociative States ScaleAdministration of lamotrigineAdministration of ketamineDouble-blind conditionsNMDA receptor antagonistMood-elevating effectsPositive symptom subscaleBrief Psychiatric RatingNovel therapeutic agentsNegative symptom subscaleHopkins Verbal Learning TestVerbal Learning TestKetamine effectsPsychiatric illnessHealthy subjectsPathophysiologic processesPreclinical studiesAntidepressant effects of ketamine in depressed patients
Berman R, Cappiello A, Anand A, Oren D, Heninger G, Charney D, Krystal J. Antidepressant effects of ketamine in depressed patients. Biological Psychiatry 2000, 47: 351-354. PMID: 10686270, DOI: 10.1016/s0006-3223(99)00230-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntidepressive AgentsDepressive Disorder, MajorDose-Response Relationship, DrugDouble-Blind MethodExcitatory Amino Acid AntagonistsFemaleGlutamic AcidHumansInjections, IntravenousKetamineMaleMiddle AgedPsychiatric Status Rating ScalesReceptors, N-Methyl-D-AspartateSeverity of Illness IndexConceptsMajor depressionN-methyl-D-aspartate receptor antagonistBrain glutamate systemDouble-blind trialDouble-blind conditionsTreatment of depressionMechanism of actionPlacebo infusionAntidepressant effectsIntravenous treatmentSingle doseReceptor antagonistDepressed patientsGlutamate systemDepressive symptomsPreclinical researchKetamine hydrochlorideDepressionPotential roleTest dayTreatment effectsPatientsKetamineSaline solutionTreatment
1999
The use of pindolol with fluoxetine in the treatment of major depression: final results from a double-blind, placebo-controlled trial
Berman R, Anand A, Cappiello A, Miller H, Hu X, Oren D, Charney D. The use of pindolol with fluoxetine in the treatment of major depression: final results from a double-blind, placebo-controlled trial. Biological Psychiatry 1999, 45: 1170-1177. PMID: 10331109, DOI: 10.1016/s0006-3223(98)00383-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultDepressive DisorderDouble-Blind MethodFemaleFluoxetineHumansMaleMiddle AgedPindololConceptsPlacebo groupClinical responseMore weeksDrug-free outpatientsEfficacy of pindololPartial remission rateUse of pindololPlacebo-controlled trialDouble-blind mannerMajor depressive episodeSingle-blind mannerPindolol groupPindolol treatmentPartial remissionRemission rateBlood pressureReuptake inhibitorsStudy endPatient populationDepressive episodeDepressed patientsMajor depressionRecurrent depressionSide effectsControl groupTransient Depressive Relapse Induced by Catecholamine Depletion: Potential Phenotypic Vulnerability Marker?
Berman RM, Narasimhan M, Miller HL, Anand A, Cappiello A, Oren DA, Heninger GR, Charney DS. Transient Depressive Relapse Induced by Catecholamine Depletion: Potential Phenotypic Vulnerability Marker? JAMA Psychiatry 1999, 56: 395-403. PMID: 10232292, DOI: 10.1001/archpsyc.56.5.395.Peer-Reviewed Original ResearchConceptsCatecholamine depletionMedication-free subjectsMajor depressionHamilton Depression Rating Scale scoresDepression Rating Scale scoresBaseline plasma cortisol levelsDepressive reactionsSignificant depressive symptomsRating Scale scoresHistory of depressionState-related alterationsPlasma cortisol levelsCatecholamine functionAlpha-methylparatyrosineRelapse criteriaBlood samplesDepressive symptomsCortisol levelsCrossover designScale scoreDepressed subjectsReliable markerTransient increaseVulnerability markerAnxiety symptomsEffect of catecholamine depletion on lithium-induced long-term remission of bipolar disorder
Anand A, Darnell A, Miller H, Berman R, Cappiello A, Oren D, Woods S, Charney D. Effect of catecholamine depletion on lithium-induced long-term remission of bipolar disorder. Biological Psychiatry 1999, 45: 972-978. PMID: 10386179, DOI: 10.1016/s0006-3223(98)00293-5.Peer-Reviewed Original ResearchConceptsLong-term remissionBipolar disorderCatecholamine depletionLithium therapyHypomanic symptomsLong-term lithium therapyRandomized double-blind mannerDSM-IV bipolar disorderDouble-blind mannerMechanism of preventionTransient relapseManic relapsePlacebo administrationSerum levelsCatecholamine systemsHomovanillic acidRemissionRelapseDisordersTherapyTest sessionsSymptomsSubjectsSignificant changesMood indices
1994
A controlled trial of cyanocobalamin (Vitamin B12) in the treatment of winter seasonal affective disorder
Oren D, Teicher M, Schwartz P, Glod C, Turner E, Ito Y, Sedway J, Rosenthal N, Wehr T. A controlled trial of cyanocobalamin (Vitamin B12) in the treatment of winter seasonal affective disorder. Journal Of Affective Disorders 1994, 32: 197-200. PMID: 7852661, DOI: 10.1016/0165-0327(94)90018-3.Peer-Reviewed Original ResearchMeSH KeywordsAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedPlacebosPsychiatric Status Rating ScalesSeasonal Affective DisorderTreatment OutcomeVitamin B 12ConceptsSeasonal affective disorderWinter seasonal affective disorderAffective disordersEffective short-term treatmentWeekly outpatient visitsShort-term treatmentSIGH-SAD scoresPlacebo washoutAntidepressant efficacyOutpatient visitsWashout periodEffective treatmentSame scheduleVitamin B12SAD patientsSignificant differencesTreatmentPatientsWeeksDisordersCyanocobalaminRandom assignmentPlaceboTrialsVisitsA Controlled Trial of Levodopa Plus Carbidopa in the Treatment of Winter Seasonal Affective Disorder
OREN D, MOUL D, SCHWARTZ P, WEHR T, ROSENTHAL N. A Controlled Trial of Levodopa Plus Carbidopa in the Treatment of Winter Seasonal Affective Disorder. Journal Of Clinical Psychopharmacology 1994, 14: 196-200. PMID: 8027416, DOI: 10.1097/00004714-199406000-00007.Peer-Reviewed Original ResearchConceptsSeasonal affective disorderWinter seasonal affective disorderDopaminergic deficiencyAffective disordersItem Hamilton Rating ScaleEfficacy of levodopaUse of levodopaWeekly outpatient visitsHamilton Rating ScalePlacebo washoutAntidepressant efficacyOutpatient visitsWashout periodRate of responseDepression scoresPatientsLevodopaPlaceboCarbidopaRating ScaleIdentical scheduleSAD patientsTreatmentWeeksDisorders