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Deep Brain Stimulation for Refractory Major Depression

16. februar 2009 opdateret af: University Health Network, Toronto
Despite many available treatments, there are patients with major depression who remain treatment refractory and chronically disabled. For these severely ill patients, several neurosurgical procedures are available where brain lesions are made that interrupt white matter tracts linking orbital frontal cortex to the striatum, resulting in significant therapeutic benefit for many patients. In this study, we will test the safety and efficacy of Deep Brain Stimulation (DBS)--a reversible method used to modulate brain activity--as an alternative to the standard subcaudate tractotomy (SCT). The physiological consequences of this procedure will be mapped longitudinally using positron emission tomography (PET) measures of brain glucose metabolism. Patients will be clinically monitored for 1 year with longitudinal psychiatric, neurological, neurosurgical, neuropsychological and PET imaging examinations to assess treatment efficacy and side effects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Study Design Subjects: Ten patients will be enrolled in this pilot study. Eligibility criteria: (i) age 30-70 years old, (ii) diagnosis of refractory unipolar major depression, (iii) recurrent illness with a minimum four major depressive episodes, (iv) current episode duration of no less than twelve months; (v) current episode treatment failure to a minimum of four treatment classes-including serotonin-reuptake inhibitors (SSRI), other novel agents, monoamine oxidase inhibitors (MAOI), tricyclics; somatic treatments such as ECT or vagus nerve stimulation (VNS); some form of psychotherapy. Exclusion criteria (i) previous brain surgery (ii) neurological disorder of any type, (iii) significant psychiatric comorbidity as defined by DSM IV diagnostic criteria (such as schizophrenia, panic disorder) (iv) serious medical conditions or contraindication for surgery such as cardiac pacemaker/defibrillator or other implanted devices. Full medical records from a treating psychiatrist will first be reviewed by Dr. Kennedy. Eligible patients will then undergo a full psychiatric, neurological and neuropsychological evaluation (Appendix 1 and 2). Final selection will be made by consensus of the investigative team in collaboration with a senior independent psychiatrist Robert Cooke, MD with expertise in intractable mood disorders. Informed consent will be obtained prior to entering the study.

Undersøgelsestype

Interventionel

Tilmelding

10

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • University Health Network

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 30-70; men and women (non-pregnant)
  • Diagnosis: major depressive episode (unipolar) by DSM-IV derived from the SCID-P.
  • Recurrent disease; minimum 4 major depressive episodes .
  • Chronic illness with current episode ~ 12 months duration
  • Response failure to multiple treatment regimens. Resistance or intolerance to at least four treatments from different categories (SSRI, SNRI, TCA, HCA, MAOI, atypical, Lithium, anticonvulsants, ECT, VNS, CBT/IPT). Documentation of adequate dose and duration of each treatment.
  • Hamilton Rating Scale for Depression (HRSD-24) score >20
  • Global Assessment of Function. score ~50
  • No neurological disease; no other Axis 1 or Axis II diagnosis; no substance abuse
  • Stable on current antidepressant meditation regimen or medication free ~4 weeks
  • Able to give informed consent in accordance with institutional policies.
  • Able to comply with all testing and follow-up visit requirements defined by the Study Protocol. Pre-menopausal women must agree to use acceptable methods of birth control (radiation risk of PET)

Exclusion Criteria:

  • Atypical or psychotic subtypes of major depressive disorder.
  • Alcohol or substance dependence within 12 months; abuse within 6 months, excluding nicotine Current suicidal ideations, plan or intent for self-harm; in past 3 years, repeated suicide attempts, resulting in emergency room or inpatient care.
  • Major medical illness, cardiac pacemaker/defibrillator, and other implanted stimulator.
  • Likely to relocate or move to a location distant from the study site within one year of enrollment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Hamilton Rating Scale for Depression, 24-item version (HRSD-24)
Clinical Global Impression (CGI) of Severity/Improvement
Psychiatric assessments will be performed every two weeks in the clinic. Once final stimulation parameters are established, psychiatric symptoms will be monitored monthly.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Health Network, Toronto

Samarbejdspartnere

National Alliance for Research on Schizophrenia and Depression

Efterforskere

  • Ledende efterforsker: Andres Lozano, MD, University Health Network, Toronto
  • Ledende efterforsker: Sidney H Kennedy, MD, FRCPC, Univesity Health Network

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2002

Primær færdiggørelse (Faktiske)

1. november 2007

Datoer for studieregistrering

Først indsendt

23. februar 2006

Først indsendt, der opfyldte QC-kriterier

23. februar 2006

Først opslået (Skøn)

27. februar 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. februar 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. februar 2009

Sidst verificeret

1. september 2005

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 02-0118-B

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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