Health TrialsbyHealthPanel

Patient-oriented Randomized Pragmatic Feasibility Trial with RTMS in Depression and Anxiety

ConditionsMajor Depressive EpisodeMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of British Columbia

About this trial

This trial compares intermittent theta-burst stimulation (iTBS) to low frequency repetitive transcranial magnetic stimulation (LFR) in regards to depression and anxiety outcomes in 100 patients with treatment resistant depression (TRD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

are outpatients;

are voluntary and competent to consent to treatment;

are ≥ 18 years;

have a score ≥ 26 on the IDS-30-SR;

Disqualifiers

have active suicidal intent;

are pregnant;

have a lifetime diagnosis of schizophrenia, bipolar disorder type I, schizophreniform, schizoaffective disorder or presence of psychotic symptoms within last 3 months;

have a concomitant major unstable medical illness;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation

    Device

    rTMS will employ the MagPro X100 stimulator equipped with the cool-B70 coil (MagVenture, Farum, Denmark). The dose will be a 120% resting motor threshold (rMT) in accordance to our latest trial using iTBS. Localization of the right and left DLPFC will follow the well-established Beam F3 procedure. Subjects will then undergo 30 sessions of rTMS, once daily on weekdays for 6 weeks. FDA-approved iTBS protocol will consist of bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz for 600 pulses total, 2 s on, 8 s off, for 3 min 9 sec, at 120% rMT. LFR will consist of 1 Hz stimulation consisting of a single train of 10min duration for 600 pulses total at 120% rMT.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intermittent Theta Burst Stimulation (iTBS)Active comparator 1 intervention
Group B: Low Frequency Right (LFR)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Depression severity

Inventory of Depressive Symptoms (IDS-30-SR); Minimum value per question: 0; Maximum value per question: 3; Total minimum value: 0; Total maximum value: 84; Higher score means worse outcome.

Time frame
one week post treatment

Secondary outcomes

1

Suicidal ideation

Columbia-Suicide Severity Rating Scale (C-SSRS); This questionnaire has binary responses (Yes/No). More responses with "Yes" mean worse outcome.

Time frame
one week post treatment
2

Anxiety severity

Brief Symptom Inventory anxiety subscale (BSI-Anxiety); Minimum value per question: 0 (Not at all); Maximum value per question: 4 (Extremely); Total minimum value: 0; Total maximum value: 24; Higher score means worse outcome.

Time frame
one week post treatment

Other outcomes

Sponsors and contacts

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

University of British Columbia

Lead sponsor

Source ClinicalTrials.gov
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