NCT03626181

Brief Summary

This study investigates the brain-based biomarkers of treatment response to accelerated theta burst stimulation (aTBS) in patients with Major Depressive Disorder resistant to pharmacological treatment(MDD) in an open label design.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

July 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

July 4, 2018

Last Update Submit

August 7, 2018

Conditions

Depressive Disorder, Treatment-Resistant

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale

    Clinician administered questionnaire to asses clinical improvement and classify response and remission

    Change from baseline at 5 days of TBS treatment

Secondary Outcomes (10)

  • 1. Montgomery-Ă…sberg Depression Rating Scale (MADRS)

    Change from baseline at 5 days of TBS treatment

  • 2. Hamilton Anxiety rating Scale (HAM-A)

    Change from baseline at 5 days of TBS treatment

  • 2. Columbia Suicide Severity Rating Scale ( CSSRS)

    Change from baseline at 5 days of TBS treatment

  • MGH Rumination questionnaire

    Change from baseline at 5 days of TBS treatment

  • Snaith-Hamilton Pleasure scale-Clinician administered (SHAP-C)

    Change from baseline at 5 days of TBS treatment

  • +5 more secondary outcomes

Study Arms (1)

Active TBS-DLPFC

EXPERIMENTAL

There is only one arm. All participants will receive Theta Burst Stimulation (transcranial magnetic stimulation) of the dorsolateral prefrontal cortex.

Device: Theta Burst Stimulation ( Transcranial Magnetic Stimulation)

Interventions

Theta Burst Stimulation ( Transcranial Magnetic Stimulation)DEVICE

Participants will receive bilateral TBS, 5 times daily (15 minutes between), over 5 consecutive days (25 sessions total). In each session they will receive intermittent TBS (iTBS) over left dorsolateral prefrontal cortex (DLPFC), followed by continuous TBS (cTBS) over right DLPFC. Stimulation sites will be targeted with the Localite neuronavigation system and Visor2 software, and according to Talairach coordinates in relation to individual MRIs. Intensity will be standardized at 120% of RMT. The MagPro stimulator will deliver iTBS over left DLPFC with 1620 pulses in 54 triplet bursts (5Hz) with train duration of 2 seconds, and intertrain interval of 8 seconds. cTBS over right DLPFC will consist of 1620 pulses in 54 triplet bursts, train duration of 2 seconds, with no intertrain interval.

Active TBS-DLPFC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant must meet the DSM-5 diagnostic criteria for single-episode Major Depressive Disorder (MDD).
  • Participant must have failed to respond to \>1 but \<4 classes of oral antidepressant treatments in the current episode of depression.
  • Participant must have a HAMD total score of at least 18

You may not qualify if:

  • The participant's depressive symptoms have previously demonstrated nonresponse to:
  • An adequate course of rTMS/TBS over DLPFC in the current major depressive episode, defined as at least 3 weeks of treatment, 5 times weekly
  • An adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT.
  • Participant has received vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression.
  • Participant has a current or prior DSM-5 diagnosis of Axis I comorbidities, including psychosis, bipolar disorder, obsessive compulsive disorder, based upon clinical assessment and confirmed by the MINI.
  • Participant has a current or prior DSM-5 diagnosis of Axis II comorbidities, including severe borderline personality disorders, antisocial, schizotypal, schizoid personality disorders based upon clinical assessment and confirmed by the MINI.
  • Participant has severe suicidal ideation/plan/ intent.
  • Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria.
  • Participant has a current or past history of seizures and neurological problems, e.g. head injury, stroke, progressive neurological disorder and complicated and unstable medical disorders, e.g. cardiovascular-related conditions, diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Related Publications (10)

  • Duprat R, Desmyter S, Rudi de R, van Heeringen K, Van den Abbeele D, Tandt H, Bakic J, Pourtois G, Dedoncker J, Vervaet M, Van Autreve S, Lemmens GM, Baeken C. Accelerated intermittent theta burst stimulation treatment in medication-resistant major depression: A fast road to remission? J Affect Disord. 2016 Aug;200:6-14. doi: 10.1016/j.jad.2016.04.015. Epub 2016 Apr 19.

    PMID: 27107779RESULT

  • Desmyter S, Duprat R, Baeken C, Van Autreve S, Audenaert K, van Heeringen K. Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial. Front Hum Neurosci. 2016 Sep 27;10:480. doi: 10.3389/fnhum.2016.00480. eCollection 2016.

    PMID: 27729854RESULT

  • Fitzgerald PB, Hoy KE, Elliot D, Susan McQueen RN, Wambeek LE, Daskalakis ZJ. Accelerated repetitive transcranial magnetic stimulation in the treatment of depression. Neuropsychopharmacology. 2018 Jun;43(7):1565-1572. doi: 10.1038/s41386-018-0009-9. Epub 2018 Feb 5.

    PMID: 29467437RESULT

  • Holtzheimer PE 3rd, McDonald WM, Mufti M, Kelley ME, Quinn S, Corso G, Epstein CM. Accelerated repetitive transcranial magnetic stimulation for treatment-resistant depression. Depress Anxiety. 2010 Oct;27(10):960-3. doi: 10.1002/da.20731.

    PMID: 20734360RESULT

  • Li CT, Chen MH, Juan CH, Huang HH, Chen LF, Hsieh JC, Tu PC, Bai YM, Tsai SJ, Lee YC, Su TP. Efficacy of prefrontal theta-burst stimulation in refractory depression: a randomized sham-controlled study. Brain. 2014 Jul;137(Pt 7):2088-98. doi: 10.1093/brain/awu109. Epub 2014 May 10.

    PMID: 24817188RESULT

  • Oberman L, Edwards D, Eldaief M, Pascual-Leone A. Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. J Clin Neurophysiol. 2011 Feb;28(1):67-74. doi: 10.1097/WNP.0b013e318205135f.

    PMID: 21221011RESULT

  • Bakker N, Shahab S, Giacobbe P, Blumberger DM, Daskalakis ZJ, Kennedy SH, Downar J. rTMS of the dorsomedial prefrontal cortex for major depression: safety, tolerability, effectiveness, and outcome predictors for 10 Hz versus intermittent theta-burst stimulation. Brain Stimul. 2015 Mar-Apr;8(2):208-15. doi: 10.1016/j.brs.2014.11.002. Epub 2014 Nov 6.

    PMID: 25465290RESULT

  • Blumberger DM, Maller JJ, Thomson L, Mulsant BH, Rajji TK, Maher M, Brown PE, Downar J, Vila-Rodriguez F, Fitzgerald PB, Daskalakis ZJ. Unilateral and bilateral MRI-targeted repetitive transcranial magnetic stimulation for treatment-resistant depression: a randomized controlled study. J Psychiatry Neurosci. 2016 Jun;41(4):E58-66. doi: 10.1503/jpn.150265.

    PMID: 27269205RESULT

  • Brunoni AR, Chaimani A, Moffa AH, Razza LB, Gattaz WF, Daskalakis ZJ, Carvalho AF. Repetitive Transcranial Magnetic Stimulation for the Acute Treatment of Major Depressive Episodes: A Systematic Review With Network Meta-analysis. JAMA Psychiatry. 2017 Feb 1;74(2):143-152. doi: 10.1001/jamapsychiatry.2016.3644.

    PMID: 28030740RESULT

  • Chung SW, Hoy KE, Fitzgerald PB. Theta-burst stimulation: a new form of TMS treatment for depression? Depress Anxiety. 2015 Mar;32(3):182-92. doi: 10.1002/da.22335. Epub 2014 Nov 28.

    PMID: 25450537RESULT

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Rajamannar Ramasubbu, MD,FRCPC,MSc

    University of Calgary, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajamannar Ramasubbu, MD,FRCPC,MSc

CONTACT

403-210-6890rramasub@ucalgary.ca

Laina B McAusland, RN,MSc

CONTACT

403-210-6905lbsorens@ucalgary.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 4, 2018

First Posted

August 10, 2018

Study Start

July 6, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

CA(1)