2024
Psilocybin pulse regimen reduces cluster headache attack frequency in the blinded extension phase of a randomized controlled trial
Schindler E, Sewell R, Gottschalk C, Flynn L, Zhu Y, Pittman B, Cozzi N, D'Souza D. Psilocybin pulse regimen reduces cluster headache attack frequency in the blinded extension phase of a randomized controlled trial. Journal Of The Neurological Sciences 2024, 460: 122993. PMID: 38581739, DOI: 10.1016/j.jns.2024.122993.Peer-Reviewed Original ResearchMeSH KeywordsAdultCluster HeadacheDouble-Blind MethodFemaleHallucinogensHumansMaleMiddle AgedPsilocybinTreatment OutcomeConceptsAttack frequencyCluster headacheCluster headache attack frequencyExtension phaseEffects of repeated treatmentReduction of attack frequencyPlacebo-controlled studyHeadache attack frequencyAdministration of psilocybinRandomized controlled trialsDouble-blindPsilocybin administrationPulse regimenAdverse eventsPulse regimensHeadache diaryTherapeutic efficacyDrug sessionsPulse administrationHeadacheStudy participantsWeeks
2022
Exploratory investigation of a patient‐informed low‐dose psilocybin pulse regimen in the suppression of cluster headache: Results from a randomized, double‐blind, placebo‐controlled trial
Schindler E, Sewell R, Gottschalk C, Luddy C, Flynn L, Zhu Y, Lindsey H, Pittman B, Cozzi N, D'Souza D. Exploratory investigation of a patient‐informed low‐dose psilocybin pulse regimen in the suppression of cluster headache: Results from a randomized, double‐blind, placebo‐controlled trial. Headache The Journal Of Head And Face Pain 2022, 62: 1383-1394. PMID: 36416492, DOI: 10.1111/head.14420.Peer-Reviewed Original ResearchConceptsAttacks/weekPulse regimenCluster headachePsychotropic effectsAttack frequencyPlacebo-controlled studyPlacebo-controlled trialSerious adverse eventsEffects of psilocybinEffect sizeChronic participantsEfficacy outcomesAdverse eventsModerate effect sizeHeadache burdenHeadache disordersTherapeutic effectHeadache diaryPsilocybin administrationDrug sessionsExperimental drugsRegimenPsilocybin-containing mushroomsDefinitive studiesFinal analysisDose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial
Abdallah CG, Roache JD, Gueorguieva R, Averill LA, Young-McCaughan S, Shiroma PR, Purohit P, Brundige A, Murff W, Ahn KH, Sherif MA, Baltutis EJ, Ranganathan M, D’Souza D, Martini B, Southwick SM, Petrakis IL, Burson RR, Guthmiller KB, López-Roca AL, Lautenschlager KA, McCallin JP, Hoch MB, Timchenko A, Souza SE, Bryant CE, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH. Dose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial. Neuropsychopharmacology 2022, 47: 1574-1581. PMID: 35046508, PMCID: PMC8767037, DOI: 10.1038/s41386-022-01266-9.Peer-Reviewed Original ResearchMeSH KeywordsAntidepressive AgentsDouble-Blind MethodHumansKetamineMilitary PersonnelStress Disorders, Post-TraumaticTreatment OutcomeVeteransConceptsPosttraumatic stress disorderClinical trialsOutcome measuresMontgomery-Åsberg Depression Rating ScaleSelf-report PTSD ChecklistÅsberg Depression Rating ScaleStress disorderPTSD symptomsAntidepressant-resistant symptomsPrevious antidepressant treatmentClinician-Administered PTSD ScaleMulti-center clinical trialRapid antidepressant effectsSecondary outcome measuresPrimary outcome measureSignificant dose-related effectsRole of ketamineDepression Rating ScaleDose-related effectsEffects of ketamineDSM-5Intravenous placeboDose ketamineTreatment discontinuationActive duty military
2020
Modulation of the antidepressant effects of ketamine by the mTORC1 inhibitor rapamycin
Abdallah CG, Averill LA, Gueorguieva R, Goktas S, Purohit P, Ranganathan M, Sherif M, Ahn KH, D’Souza D, Formica R, Southwick SM, Duman RS, Sanacora G, Krystal JH. Modulation of the antidepressant effects of ketamine by the mTORC1 inhibitor rapamycin. Neuropsychopharmacology 2020, 45: 990-997. PMID: 32092760, PMCID: PMC7162891, DOI: 10.1038/s41386-020-0644-9.Peer-Reviewed Original ResearchMeSH KeywordsAntidepressive AgentsDepressive Disorder, MajorHumansKetamineMechanistic Target of Rapamycin Complex 1SirolimusTreatment OutcomeConceptsAntidepressant effectsKetamine administrationRapamycin pretreatmentMontgomery-Åsberg Depression Rating ScaleDouble-blind cross-over designBenefits of ketamineRobust antidepressant effectsKetamine's antidepressant effectsMajor depressive episodeDepression Rating ScaleCross-over designKetamine exertsOral rapamycinRemission rateDepressive episodePlacebo 2Ketamine 0.5Local blockadeDepressed patientsIntravenous administrationTreatment daysDepression relapseDepression severityKetamineRating Scale
2018
Efficacy and safety of a fatty acid amide hydrolase inhibitor (PF-04457845) in the treatment of cannabis withdrawal and dependence in men: a double-blind, placebo-controlled, parallel group, phase 2a single-site randomised controlled trial
D'Souza DC, Cortes-Briones J, Creatura G, Bluez G, Thurnauer H, Deaso E, Bielen K, Surti T, Radhakrishnan R, Gupta A, Gupta S, Cahill J, Sherif MA, Makriyannis A, Morgan PT, Ranganathan M, Skosnik PD. Efficacy and safety of a fatty acid amide hydrolase inhibitor (PF-04457845) in the treatment of cannabis withdrawal and dependence in men: a double-blind, placebo-controlled, parallel group, phase 2a single-site randomised controlled trial. The Lancet Psychiatry 2018, 6: 35-45. PMID: 30528676, DOI: 10.1016/s2215-0366(18)30427-9.Peer-Reviewed Original ResearchConceptsPF-04457845Cannabis withdrawal symptomsFatty acid amide hydrolaseCannabis withdrawalPlacebo groupAdverse eventsCannabis useWithdrawal symptomsFatty acid amide hydrolase inhibitorSerious adverse eventsPhase 2a trialWeeks of treatmentTreatment of cannabisCannabis use disorderSelf-reported cannabis useDSM-IV criteriaTreatment-related differencesTHC-COOH concentrationsAnandamide concentrationsTreat populationPrimary endpointPill countHospital admissionNovel FAAH inhibitorsSelf-reported cannabisHerpes simplex virus 1 infection and valacyclovir treatment in schizophrenia: Results from the VISTA study
Breier A, Buchanan RW, D'Souza D, Nuechterlein K, Marder S, Dunn W, Preskorn S, Macaluso M, Wurfel B, Maguire G, Kakar R, Highum D, Hoffmeyer D, Coskinas E, Litman R, Vohs JL, Radnovich A, Francis MM, Metzler E, Visco A, Mehdiyoun N, Yang Z, Zhang Y, Yolken RH, Dickerson FB. Herpes simplex virus 1 infection and valacyclovir treatment in schizophrenia: Results from the VISTA study. Schizophrenia Research 2018, 206: 291-299. PMID: 30478008, DOI: 10.1016/j.schres.2018.11.002.Peer-Reviewed Original ResearchConceptsHSV-1Double-blind efficacy trialHerpes simplex virus 1 (HSV-1) infectionEarly phase schizophreniaSimplex virus 1 infectionVirus-1 infectionPathophysiology of schizophreniaPrimary endpointValacyclovir treatmentNegative subjectsRecent trialsVISTA studyEfficacy trialsLetter-Number Sequencing TestNegative groupPositive groupSevere formHerpes virusPositive symptomsMore impairmentTreatment resultsUS sitesCognitive deficitsNon-activated stateSchizophreniaThe effects of cannabidiol (CBD) on cognition and symptoms in outpatients with chronic schizophrenia a randomized placebo controlled trial
Boggs DL, Surti T, Gupta A, Gupta S, Niciu M, Pittman B, Schnakenberg Martin AM, Thurnauer H, Davies A, D’Souza D, Ranganathan M. The effects of cannabidiol (CBD) on cognition and symptoms in outpatients with chronic schizophrenia a randomized placebo controlled trial. Psychopharmacology 2018, 235: 1923-1932. PMID: 29619533, DOI: 10.1007/s00213-018-4885-9.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAffectAntipsychotic AgentsCannabidiolChronic DiseaseCognitionCognitive DysfunctionDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMental Status and Dementia TestsMiddle AgedOutpatientsPsychiatric Status Rating ScalesSchizophreniaSchizophrenic PsychologyTreatment OutcomeConceptsMATRICS Consensus Cognitive BatterySide effectsChronic schizophreniaAntipsychotic-treated patientsMovement side effectsFixed-dose studyPlacebo-treated subjectsWeeks of treatmentPANSS total scoreEffects of cannabidiolWorsening of moodNegative Syndrome ScaleAntipsychotic-treated outpatients× time effect× time interactionMCCB composite scoreOral cannabidiolCBD groupClinical trialsParallel groupPANSS scoresMethodsThis studyPsychotic symptomsConsensus Cognitive BatterySyndrome Scale
2012
Efficacy of pimozide augmentation for clozapine partial responders with schizophrenia
Gunduz-Bruce H, Oliver S, Gueorguieva R, Forselius-Bielen K, D'Souza DC, Zimolo Z, Tek C, Kaliora S, Ray S, Petrides G. Efficacy of pimozide augmentation for clozapine partial responders with schizophrenia. Schizophrenia Research 2012, 143: 344-347. PMID: 23219861, DOI: 10.1016/j.schres.2012.11.008.Peer-Reviewed Original ResearchConceptsBrief Psychiatric Rating ScaleTreatment-resistant schizophreniaClinical trialsNegative symptomsDouble-blind placeboAdequate blood levelsPsychiatric Rating ScaleNeurocognitive measuresAttention/executive functionBPRS totalPartial respondersPartial responseStudy entryQTc intervalBlood levelsClozapine's effectSide effectsNeurocognitive functionPatientsWeekly assessmentsClozapineNeurocognitive testsRating ScaleSchizophreniaTrialsFeasibility, Safety, and Efficacy of the Combination of D-Serine and Computerized Cognitive Retraining in Schizophrenia: An International Collaborative Pilot Study
D'Souza DC, Radhakrishnan R, Perry E, Bhakta S, Singh NM, Yadav R, Abi-Saab D, Pittman B, Chaturvedi SK, Sharma MP, Bell M, Andrade C. Feasibility, Safety, and Efficacy of the Combination of D-Serine and Computerized Cognitive Retraining in Schizophrenia: An International Collaborative Pilot Study. Neuropsychopharmacology 2012, 38: 492-503. PMID: 23093223, PMCID: PMC3547200, DOI: 10.1038/npp.2012.208.Peer-Reviewed Original ResearchConceptsCognitive retrainingCognitive deficitsVerbal Working MemoryCognitive remediation strategiesAttention/vigilanceBasic information processingIndividual test performanceGlobal cognitive indexWorking memoryD-serineCognitive indicesCombination of pharmacotherapyTest performanceInformation processingMulticenter international clinical trialParallel group designSchizophrenia subjectsCollaborative pilot studyInternational clinical trialsUS samplePreliminary findingsCombination pharmacotherapySchizophreniaClinical trialsOutcome measuresFeasibility and pilot efficacy results from the multisite Cognitive Remediation in the Schizophrenia Trials Network (CRSTN) randomized controlled trial.
Keefe RS, Vinogradov S, Medalia A, Buckley PF, Caroff SN, D'Souza DC, Harvey PD, Graham KA, Hamer RM, Marder SM, Miller DD, Olson SJ, Patel JK, Velligan D, Walker TM, Haim AJ, Stroup TS. Feasibility and pilot efficacy results from the multisite Cognitive Remediation in the Schizophrenia Trials Network (CRSTN) randomized controlled trial. The Journal Of Clinical Psychiatry 2012, 73: 1016-22. PMID: 22687548, PMCID: PMC3746329, DOI: 10.4088/jcp.11m07100.Peer-Reviewed Original Research
2010
Armodafinil as adjunctive therapy in adults with cognitive deficits associated with schizophrenia: a 4-week, double-blind, placebo-controlled study.
Kane JM, D'Souza DC, Patkar AA, Youakim JM, Tiller JM, Yang R, Keefe RS. Armodafinil as adjunctive therapy in adults with cognitive deficits associated with schizophrenia: a 4-week, double-blind, placebo-controlled study. The Journal Of Clinical Psychiatry 2010, 71: 1475-81. PMID: 20816042, DOI: 10.4088/jcp.09m05950gry.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntipsychotic AgentsBenzhydryl CompoundsBenzodiazepinesCentral Nervous System StimulantsCognition DisordersDouble-Blind MethodDrug Therapy, CombinationFemaleHumansIsoxazolesMaleMiddle AgedModafinilOlanzapinePaliperidone PalmitatePsychiatric Status Rating ScalesPyrimidinesRisperidoneSchizophreniaTreatment OutcomeConceptsAdjunctive armodafinilAdjunctive therapyFinal visitNegative symptomsTotal scoreIsomer of modafinilTolerability of armodafinilPlacebo-controlled studyPrimary efficacy measureSecondary outcome measuresPANSS total scoreSANS total scoreNegative symptom scoresNegative Syndrome ScaleDaily placeboStable dosesAdverse eventsOral risperidoneSymptom scoresEfficacy measuresSchizophrenia (MATRICS) Consensus Cognitive BatteryOutcome measuresStable schizophreniaSD changeArmodafinilHigh dose D-serine in the treatment of schizophrenia
Kantrowitz JT, Malhotra AK, Cornblatt B, Silipo G, Balla A, Suckow RF, D'Souza C, Saksa J, Woods SW, Javitt DC. High dose D-serine in the treatment of schizophrenia. Schizophrenia Research 2010, 121: 125-130. PMID: 20541910, PMCID: PMC3111070, DOI: 10.1016/j.schres.2010.05.012.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAnalysis of VarianceAntipsychotic AgentsChi-Square DistributionCognition DisordersDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansMaleMiddle AgedNeuropsychological TestsPsychiatric Status Rating ScalesRegression AnalysisSchizophreniaSerineTreatment OutcomeYoung AdultConceptsD-serineBrain N-methyl-D-aspartate receptorsPlasma D-serine levelsN-methyl-D-aspartate receptorsSafety of dosesSignificant dose-dependent increaseDouble-blind investigationOpen-label trialDose-escalation studyDouble-blind studyLarge effect size improvementsTreatment of schizophreniaD-serine levelsPotential novel treatmentPharmacokinetics/pharmacodynamicsDose-dependent increaseNon-significant improvementEffect size improvementsMedication phasePersistent symptomsEscalation studyBrain levelsPlasma levelsPK analysisNeurocognitive dysfunction