Comparing Different Patterns of rTMS in Major Depression
13 mars 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
180
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ontario
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Toronto, Ontario, Canada, M6J 1H4
- Recrutement
- Centre for Addiction and Mental Health
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Contact:
- Shobha Mehta
- E-mail: shobha.mehta@camh.ca
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Chercheur principal:
- Daniel M Blumberger, MD MSc
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Sous-enquêteur:
- Zafiris J Daskalakis, MD PhD
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Toronto, Ontario, Canada, M5T 2S8
- Recrutement
- UHN MRI-Guided rTMS Clinic, Toronto Western Hospital
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Contact:
- Laura Schulze
- Numéro de téléphone: 416-603-5667
- E-mail: laura.schulze@uhn.ca
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Contact:
- Terri Cairo
- Numéro de téléphone: 416-603-5667
- E-mail: terri.cairo@uhn.ca
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Chercheur principal:
- Jonathan Downar, MD PhD FRCPC
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Participants are eligible for the study if they:
- are outpatients
- are voluntary and competent to consent to treatment
- 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
- are between the ages of 18 and 65
- 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)
- have a score ≥18 on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
- have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
- are able to adhere to the treatment schedule
- pass the TMS safety-screening questionnaire
- 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:
- have a history of substance dependence or abuse within the last 3 months
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- have active suicidal intent
- are pregnant
- have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
- 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
- have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
- have failed a course of electroconvulsive therapy (ECT) in the current episode or previous episode
- 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
- 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
- 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
- have a clinically significant laboratory abnormality, in the opinion of the investigator
- 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
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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).
|
Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval
|
|
Expérimental: 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).
|
Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval
|
|
Expérimental: 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).
|
Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
17-Item Hamilton Rating Scale for Depression (HAMD-17)
Délai: 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.
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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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Beck Depression Inventory-II (BDI-II)
Délai: 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
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 avril 2016
Achèvement primaire (Anticipé)
1 mars 2019
Achèvement de l'étude (Anticipé)
1 septembre 2019
Dates d'inscription aux études
Première soumission
12 mai 2016
Première soumission répondant aux critères de contrôle qualité
18 mai 2016
Première publication (Estimation)
19 mai 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 mars 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 mars 2018
Dernière vérification
1 février 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 15-9615
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