Recruiting

Theta Burst Stimulation

Sponsor:

University of Calgary

Code:

NCT03626181

Conditions

Depressive Disorder, Treatment-Resistant

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Theta Burst Stimulation ( Transcranial Magnetic Stimulation)

Study Details

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.

Conditions

Depressive Disorder, Treatment-Resistant

Study ID

NCT03626181

Start date

Jul 6, 2018

Status verified date

Aug, 2018

Completion date

Jul 1, 2019

Anticipated

Primary completion date

Jul 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Participant has received vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression.
3. 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.
4. 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.
5. Participant has severe suicidal ideation/plan/ intent.
6. Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria.
7. 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active TBS-DLPFC

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

Interventions

Theta Burst Stimulation ( Transcranial Magnetic Stimulation)

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.

Primary outcome measure

  • Hamilton Depression Rating Scale [ Time Frame: Change from baseline at 5 days of TBS treatment ]

Central Contacts and Locations

Central contacts

Rajamannar Ramasubbu, MD,FRCPC,MSc

403-210-6890rramasub@ucalgary.ca

Laina B McAusland, RN,MSc

403-210-6905lbsorens@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

More Information

Sponsor

University of Calgary

Last update posted

Aug 10, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2018-08-10.