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Comparing Different Patterns of rTMS in Major Depression

13. marts 2018 opdateret af: University Health Network, Toronto

A Randomized Controlled Trial Comparing Different Patterns of Repetitive Transcranial Magnetic Stimulation in the Treatment of Refractory Depression

This trial will compare the trajectories of improvement for three different patterns of twice-daily rTMS in major depression: two daily sessions of dorsomedial prefrontal rTMS delivered at 0 min vs. 30 min vs. 60 min intervals.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

180

Fase

  • Ikke anvendelig

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, M6J 1H4
        • Rekruttering
        • Centre for Addiction and Mental Health
        • Kontakt:
        • Ledende efterforsker:
          • Daniel M Blumberger, MD MSc
        • Underforsker:
          • Zafiris J Daskalakis, MD PhD
      • Toronto, Ontario, Canada, M5T 2S8
        • Rekruttering
        • UHN MRI-Guided rTMS Clinic, Toronto Western Hospital
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Jonathan Downar, MD PhD FRCPC

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Participants are eligible for the study if they:

  1. are outpatients
  2. are voluntary and competent to consent to treatment
  3. have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of major depressive disorder (MDD), single or recurrent, or Bipolar Disorder with a current Major Depressive Episode
  4. are between the ages of 18 and 65
  5. have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of > 3 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
  6. have a score ≥18 on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
  7. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
  8. are able to adhere to the treatment schedule
  9. pass the TMS safety-screening questionnaire
  10. have normal thyroid functioning and no clinically significant abnormalities on complete blood count (CBC), on pre-study blood work.

Participants are ineligible for the study if they:

  1. have a history of substance dependence or abuse within the last 3 months
  2. have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
  3. have active suicidal intent
  4. are pregnant
  5. have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
  6. have a MINI diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary and causing greater impairment than MDD
  7. have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
  8. have failed a course of electroconvulsive therapy (ECT) in the current episode or previous episode
  9. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes
  10. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
  11. if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
  12. have a clinically significant laboratory abnormality, in the opinion of the investigator
  13. currently (or in the last 4 weeks prior to the study) have taken more than lorazepam 4 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
  14. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 60 min inter-session interval
Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 60 min).
Enhed: Dorsomedial prefrontal rTMS
Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval
Eksperimentel: 30 min inter-session interval
Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 30 min).
Enhed: Dorsomedial prefrontal rTMS
Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval
Eksperimentel: 0 min inter-session interval
Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 0 min).
Enhed: Dorsomedial prefrontal rTMS
Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
17-Item Hamilton Rating Scale for Depression (HAMD-17)
Tidsramme: Baseline, after each week of treatment (i.e. after 5 days of treatment), and 1, 4, and 12 weeks post-treatment. Treatment will include 5 daily weekday visits over 4 weeks (20 sessions total).
Outcome measured by a change in HAMD-17 score from baseline to 1-week post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of ≤7 is categorized as remission.
Baseline, after each week of treatment (i.e. after 5 days of treatment), and 1, 4, and 12 weeks post-treatment. Treatment will include 5 daily weekday visits over 4 weeks (20 sessions total).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Beck Depression Inventory-II (BDI-II)
Tidsramme: Daily for 4 weeks, 5 days per week, in addition to three follow-up visits at 1, 4, and 12 weeks post-treatment
Outcome measured by a change in BDI-II score from baseline to 1-week post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of ≤12 is categorized as remission.
Daily for 4 weeks, 5 days per week, in addition to three follow-up visits at 1, 4, and 12 weeks post-treatment

Samarbejdspartnere og efterforskere

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

Sponsor

University Health Network, Toronto

Samarbejdspartnere

Centre for Addiction and Mental Health

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 (Faktiske)

1. april 2016

Primær færdiggørelse (Forventet)

1. marts 2019

Studieafslutning (Forventet)

1. september 2019

Datoer for studieregistrering

Først indsendt

12. maj 2016

Først indsendt, der opfyldte QC-kriterier

18. maj 2016

Først opslået (Skøn)

19. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. marts 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15-9615

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 .

Kliniske forsøg med Depression; Bipolar Disorder

Kliniske forsøg med Dorsomedial prefrontal rTMS

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

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CROs in Jamaica

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner