Health Trials

Left vs. Right Non-Inferiority Trial

ConditionsDepressionMajor Depressive DisorderMajor Depressive Episode
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of British Columbia

About this trial

The aim of this study is to test the hypothesis that low-frequency rTMS (LFR) works as well as the established intermittent thetaburst rTMS (iTBS) treatment for treatment resistant depression (TRD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

are female or male;

are outpatients;

are voluntary and competent to consent to treatment;

have a DSM 5 diagnosis of MDD,55 single or recurrent confirmed by Mini-International Neuropsychiatric Interview (MINI) version 7.0;

Disqualifiers

have a history of substance use within the last 3 months;

have a concomitant major unstable medical illness;

have active suicidal intent;

are pregnant;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation

    Device

    rTMS will employ the MagPro X100/R30 stimulator equipped with the cool-B70 as we used a cool-B70 in our past non-inferiority trial. The dose will be a 120% rMT in accordance to our latest trial using iTBS. The target area to stimulate will be the right dorsolateral prefrontal cortex (DLPFC) for LFR and the left DLPFC for iTBS as established in prior clinical trials. The localization of both targets will follow the well-established procedures for either R-DLPFC or L-DLPFC using a heuristic method.

  • Intermittent Theta Burst Stimulation (iTBS)

    Device

    Intermittent Theta Burst Stimulation (iTBS)

  • Low Frequency Right (LFR)

    Device

    Low Frequency Right (LFR)

Treatment groups

480 Participants
are divided into 2 treatment groups
Group A: Intermittent Theta Burst Stimulation (iTBS)Active comparator 2 interventions
Group B: Low Frequency Right (LFR)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Depression severity

17 item Hamilton Depression Rating Scale (HDRS-17) Change

Time frame
30 days

Secondary outcomes

1

Suicidal ideation

Columbia Suicide Severity Rating Scale Screen Version (C-SSRS) Change

Time frame
30 days
2

Anxiety severity

Hamilton Anxiety Rating Scale (HAM-A) Change

Time frame
30 days
3

Depression severity

Self-rated 16-item Quick Inventory of Depressive Symptoms (QIDS-16) Change

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Centre for Addiction and Mental Health

Collaborator

Source ClinicalTrials.gov
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