Biomarkers of Theta Burst Stimulation in Major Depressive Disorder

U

University of Calgary

Status

Unknown

Conditions

Depressive Disorder, Treatment-Resistant

Treatments

Device: Theta Burst Stimulation ( Transcranial Magnetic Stimulation)

Study type

Interventional

Funder types

Other

Identifiers

NCT03626181
10001858
RT # 10016954 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Theta burst stimulation (TBS) is a newer form of rTMS which requires less stimulation time and produces longer lasting post-stimulation effects in the cerebral cortex (4). It has been shown to be effective in inducing synaptic plasticity and has similar or better efficacy in treating depression compared to rTMS (4).Newer accelerated TBS (aTBS) protocols that condense stimulation sessions down to several days rather than weeks have shown similar response rates when compared to prolonged TBS protocols, also with similar tolerability and safety. In order to develop aTBS as an effective treatment for MDD, future research should focus on identification of reliable predictors for better outcome to TBS. The main objectives were: 1) To directly compare multiple different brain-based measures (neuroimaging and electrophysiology) to identify which has the most power in accurately predicting response to TBS compared to sham. 2) To track both short and long-term longitudinal electrophysiological (EEG) changes related to the therapeutic effects of TBS.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Active TBS-DLPFC
Experimental group
Description:
There is only one arm. All participants will receive Theta Burst Stimulation (transcranial magnetic stimulation) of the dorsolateral prefrontal cortex.
Treatment:
Device: Theta Burst Stimulation ( Transcranial Magnetic Stimulation)

Trial contacts and locations

1

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Central trial contact

Laina B McAusland, RN,MSc; Rajamannar Ramasubbu, MD,FRCPC,MSc

Data sourced from clinicaltrials.gov

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