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COMPLETEDNA

Investigating Predictors of Treatment Response in Treatment-Resistant Depression (TRD) With Interleaved TMS/fMRI

NCT03642522•University of British Columbia

Summary

The purpose of this trial is identify biomarkers of response to repetitive transcranial magnetic stimulation (rTMS) in individuals with first episode or treatment resistant depression. These biomarkers include simultaneous TMS-fMRI (functional magnetic resonance imaging), a blood smear, cognitive and behavioural assessments, questionnaires, and neurophysiology.

Detailed Description

This study is enrolling 60 individuals with treatment-resistant depression. All patients will receive four weeks of 1-Hz rTMS to the right dorsolateral prefrontal cortex (R\_DLPFC). In addition, all patients will undergo baseline and post-treatment measures, including rTMS while they are in the MRI scanner, neurophysiology (Electroencephalography (EEG)/Near-Infrared Spectroscopy (NIRS)), cognitive testing, behavioural assessments and a blood smear. There will also be a 1-week, 4-week, and 12-week follow-up following completion of the treatment course.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Patients will be included 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 MDD, single or recurrent
•4. are between the ages of 18 and 80 years
•5. have failed to achieve a clinical response to at least one adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of score ≥ 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 ≥ 22 on the IDS item
•7. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to initiation of rTMS
•8. able to adhere to the treatment schedule
•9. pass the TMS adult safety screening (TASS) questionnaire
+16 more criteria

Exclusion Criteria

•Patients are excluded 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 bipolar I or II disorder, 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 ECT in the current episode or previous episode
•9. have received rTMS for any previous indication due to the potential compromise of expectancy effects
+17 more criteria

Locations (1)

Non-Invasive Neurostimulation Therapies lab, University of British Columbia

Vancouver, British Columbia, Canada

Key Dates

Start Date

November 1, 2018

Primary Completion Date

March 30, 2020

Completion Date

August 1, 2020

Last Updated

January 12, 2021

Enrollment

ACTUAL participants

Conditions

Major Depressive DisorderDepression

Interventions

repetitive transcranial magnetic stimulation

DEVICE

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

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RECRUITINGNA

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Investigating Predictors of Treatment Response in Treatment-Resistant Depression (TRD) With Interleaved TMS/fMRI

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Readiness and Progress in Emotion Regulation Therapy

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression