487
Views
9
CrossRef citations to date
0
Altmetric
Clinical Research

Surrogate outcomes in neurology, psychiatry, and psychopharmacology

Mediciones sustitutas en neurología, psiquiatría y psicofarmacología

Marqueurs de substitution en neurologie, psychiatrie et psychopharmacologie

Pages 345-352 | Published online: 01 Apr 2022

REFERENCES

  • Biomarkers Definition Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework.Clin Phann Ther.2001698995
  • WoodcockJ.Presentation of FDA Document, Draft Guidance for Industry; Pharmacogenomic Data Submission. 13 November 2003. (See section 506[b] of the Act (21 U.S.C. sec.356]; see also Guidance for Industry: Fast Track Drug Development Programs-Designation, Development, and Application Review, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologies Evaluation and Research [September 1998] at 2 [“Section 506(b) essentially codifies in statute FDA's accelerated approval regulations.”]).
  • BarryMJ.PSA screening for prostate cancer: the current controversy-a viewpoint. Patient Outcomes Research Team for Prostatic Diseases.Ann Oncol.19989127912829932155
  • BuntingPS.Screening for prostate cancer with prostate-specific antigen: beware the biases.Clin CnimActa.20023157197
  • JohnsonJR.WilliamsG.PazdurR.End points and United States Food and Drug Administration approval of oncology drugs.J Clin Oncol.2003211404141112663734
  • BucherHC.GuyattGH.CookDJ.HolbrookA.McAlisterFA.Users' guides to the medical literature. XIX. Applying clinical trial results. A. How to use an article measuring the effect of an intervention on surrogate end points. Evidence-Based Medicine Working Group.JAMA.199928277177810463714
  • FlemingTR.Surrogate endpoints and FDA's accelerated approval process.Health Affairs.200524677815647217
  • BurnDJ.SawleGV.BrooksDJ.Differential diagnosis of Parkinson's disease, multiple system atrophy, and Steele-Richardson-Olszewski syndrome: discriminant analysis of striatal 18F-dopa PET data.J Neurol Neurosurg Psychiatry.1994572782848158173
  • MarekK.InnisR.vanDyckC.et al.[123l]beta-CIT SPECT imaging assessment of the rate of Parkinson's disease progression.Neurology.2001572089209411739831
  • MarekK.JenningsD.SeibylJ.Single-photon emission tomography and dopamine transporter imaging in Parkinson's disease.Adv Neurol.20039118319112442677
  • Parkinson Study Group. A multicenter assessment of dopamine transporter imaging with DOPASCAN/SPECT in parkinsonism.Neurology.200157(10suppl3)S52S5911775602
  • PirkerW.DjamshidianS.AsenbaumS.et al.Progression of dopaminergic degeneration in Parkinson's disease and atypical Parkinsonism: a longitudinal b-CIT SPECT study.Mov Disord.200217455311835438
  • Parkinson Study Group. Pramipexole vs levodopa as initial treatment for Parkinson disease: a randomized controlled trial.JAMA.20002841931193811035889
  • Parkinson Study Group. Dopamine transporter brain imaging to assess the effects of pramipexole vs levodopa on parkinson's disease progression.JAMA.20022871653166111926889
  • FahnS.OakesD.ShoulsonI.et al.Levodopa and the progression of Parkinson's disease.N Engl J Med.20053512498250815590952
  • VingerhoetsFJ.SnowBJ.LeeCS.SchulzerM.MakE.CalneDB.Longitudinal fluorodopa positron emission tomographic studies of the evolution of idiopathic parkinsonism.Ann Neurol.1994367597647979222
  • SnowBJ.TooyamaI.McGeerEG.et al.Human positron emission tomographic [18F]fluorodopa studies correlate with dopamine cell counts and levels.Ann Neurol.1993343243308363349
  • RibeiroMJ.VidailhetM.Loc'hC.et al.Dopaminergic function and dopamine transporter binding assessed with positron emission tomography in Parkinson's disease.Arch Neurol.20025958058611939892
  • WhoneAL.WattsRL.StoesslAJ.et al.Slower progression of Parkinson's disease with ropinirole versus levodopa: The REAL-PET study.Ann Neurol.2003549310112838524
  • FreedCR.GreenePE.BreezeRE.et al.Transplantation of embryonic dopamine neurons for severe Parkinson's disease.N Engl J Med.200134471071911236774
  • OlanowCW.KieburtzK.SternM.et al.Double-blind, placebo-controlled study of entacapone in levodopa-treated patients with stable Parkinson disease.Arch Neurol.2004611563156815477510
  • HagellP.CenciMA.Dyskinesias and dopamine cell replacement in Parkinson's disease: a clinical perspective.Brain Res Bull.20056841516324999
  • ZhangY.DawsonVL.DawsonTM.Oxidative stress and genetics in the pathogenesis of Parkinson's disease.Neurobiol Dis.2000724025010964596
  • YoudimMB.GrunblattE.Levites-RoyakY.MandelS.Drugs to prevent cell death in Parkinson's disease. Neuroprotection against oxidative stress and inflammatory gene expression.Adv Neurol.20018611512411553968
  • SchapiraAH.Disease modification in Parkinson's disease.Lancet Neurol.2004336236815157851
  • Parkinson Study Group. DATATOP: a multicenter controlled clinical trial in early Parkinson's disease.Arch Neurol.198946105210602508608
  • LandauWM.Clinical neuromythology IX. Pyramid sale in the bucket shop: DATATOP bottoms out.Neurology.199040133713392118239
  • HolsboerF.The corticosteroid receptor hypothesis of depression.Neuropsychopharmacology.20002347750111027914
  • MüllerMB.WurstW.Getting closer to affective disorders: the role of the CRH receptor system.Trends Mol Med.20041040941515310462
  • DuvalF.MokraniMC.OrtizJA.SchulzP.ChampevalC.MacherJP.Neuroendocrine predictors of the evolution of depression.Dialogues Clin Neurosci.2005727328216156385
  • lsingM.KunzelHE.BinderEB.NickelT.ModellS.HolsboerF.The combined dexamethasone/CRH test as a potential surrogate marker in depression.Prog Neuropsychopharmacol Biol Psychiatry.2005291085109315950349
  • ModellS.IsingM.HolsboerF.LauerCJ.The Munich vulnerability study on affective disorders: premorbid polysomnographic profile of affected high-risk probands.Biol Psychiatry.20055869469916018976
  • StanerL.LuthringerR.Le BonO.Sleep disturbances in affective disorders. In: Pandl-Perumal SR, Monti JM, eds.Clinical Pharmacology of Sleep, Basel, Switzerland: Birkhauser Verlag;2006101124
  • DumontGJ.De VisserSJ.CohenAF.Van GervenJM.Biomarkers for the effects of selective serotonin reuptake inhibitors (SSRIs) in healthy subjects.Br J Clin Pharmacol.20055949551015842547
  • StanerL.LuthringerR.MacherJP.Effects of antidepressant drugs on sleep EEG in patients with major depression. Mechanisms and therapeutic implications.CNS Drugs.1999114960
  • HasslerG.DrevetsW.ManjiH.CharneyD.Discovering major endophenotypes for major depression.Neuropsychopsychopharmacology.20042917651781
  • FuCH.WilliamsSC.CleareAJ.et al.Attenuation of the neural response to sad faces in major depression by antidepressant treatment: a prospective, event-related functional magnetic resonance imaging study.Arch Gen Psychiatry.20046187788915351766
  • CharneyDS.DrevetsWC.The neurobiological basis of anxiety disorders. In: Davis KL, Charney DS, Coyle JT, Nemeroff CB, eds.Neuropsychopharmacology: the Fifth Generation of Progress. Philadelphia, Pa: Lippincott Williams &Wilkins;2002901930
  • HaririAR.MattayVS.TessitoreA.et al.Serotonin transporter genetic variation and the response of the human amygdala.Science.200229740040312130784
  • HaririAR.DrabantEM.MunozKE.et al.A susceptibility gene for affective disorders and the response of the human amygdala.Arch Gen Psychiatry.20056214615215699291
  • HeinzA.BrausDF.SmolkaMN.et al.Amygdala-prefrontal coupling depends on a genetic variation of the serotonin transporter.Nat Neurosci.20058202115592465
  • HarmerCJ.MackayCE.ReidCB.CowenPJ.GoodwinGM.Antidepressant drug treatment modifies the neural processing of nonconscious threat cues.Biol Psychiatry. 2006 Feb 3;[Epub ahead of print].
  • SwerdlowNR.KoobGF.Dopamine, schizophrenia, mania, and depression: toward a unified hypothesis of cortico-striato-pallido-thalamic function.Behav Brain Sci.198710197245
  • BraffDL.GeyerMA.Sensorimotor gating and schizophrenia. Human and animal studies.Arch Gen Psychiatry.1990471811882405807
  • LightGAA.BraffDL.Human and animal studies of schizophrenia-related gating deficits.Curr Psychiatry Rep.199940
  • iegelC.WaldoM.MiznerG.AdlerLE.FreedmanR.Deficits in sensory gating in schizophrenic patients and their relatives. Evidence obtained with auditory evoked responses.Arch Gen Psychiatry.1984416076126732421
  • BoutrosNN.ZouridakisG.OverallJ.Replication and extension of P50 findings in schizophrenia.Clin Electroencephalogr.19912240451991411
  • agamotoHT.AdlerLE.HeaRA.GriffithJM.McRaeKA.FreedmanR.Gating of auditory P50 in schizophrenics: unique effects of clozapine.Biol Psychiatry.1996401811888830951
  • AdlerLE.OlincyA.CawthraEM.et al.al.Varied effects of atypical neuroleptics on P50 auditory gating in schizophrenia patients.Am J Psychiatry.20041611822182815465979
  • ChungC.RemingtonG.Predictors and markers of clozapine response.Psychopharmacology.200517931733515717209
  • MackeprangT.KristiansenKT.GlenthojBY.Effects of antipsychotics on prepulse inhibition of the startle response in drug-na'ive schizophrenic patients.Biol Psychiatry.20025286387312399139
  • LudewigK.GeyerMA.VollenweiderFX.Deficits in prepulse inhibition and habituation in never-medicated, first-episode schizophrenia.Biol Psychiatry.20035412112812873801
  • GeyerMA.Krebs-ThomsonK.BraffDL.SwerdlowNR.Pharmacological studies of prepulse inhibition models of sensorimotor gating deficits in schizophrenia: a decade in review.Psychopharmacology.200115611715411549216
  • OranjeB.Van OelCJ.Gispen-De WiedCC.VerbatenMN.KahnRS.Effects of typical and atypical antipsychotics on the prepulse inhibition of the startle reflex in patients with schizophrenia.J Clin Psychopharmacol.20022235936512172334