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Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression

ConditionsLate Life Depression (LLD)Depression - Major Depressive DisorderDepressive Disorder, Treatment-ResistantMood Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorCentre for Addiction and Mental Health

About this trial

The purpose of this trial is to compare the treatment efficacy (improvement in depressive symptoms) of accelerated TBS protocol (where participants receive multiple TBS treatments daily) to conventional TBS protocol (where participants receive a single TBS treatment daily) in late life depression. In addition, the study also aims to determine if specific patterns of stimulation are more or less effective. To do this, all participants will receive active treatments, but some of the participants in this study will receive accelerated TBS and some will receive once daily TBS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

are voluntary and competent to consent to treatment

are an outpatient

are ≥ 60 years old

have a Mini International Neuropsychiatric Interview (MINI 7.0) confirmed diagnosis of MDD, with a current MDE

Disqualifiers

have a Mini International Neuropsychiatric Interview (MINI 7.0) confirmed diagnosis of substance dependence or abuse within the last 3 months

have a concomitant major unstable medical illness as determined by one of the study physicians

have active suicidal intent

have presumed or probable dementia or clinical evidence of dementia as assessed by Short Blessed Test score ≥ 10

Trial design

Design model

Parallel

Treatments tested in this trial

  • TBS

    Device

    Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive neurostimulation that uses focused magnetic field pulses to directly stimulate cortical neurons. Theta burst stimulation (TBS) is a briefer form of patterned rTMS that has been shown to be effective against major depressive disorder. Each treatment will consist of either 1) cTBS of right DLPFC followed by iTBS of left DLPFC; or 2) iTBS of left DLPFC.

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Accelerated TBSActive comparator 1 intervention
Group B: Conventional TBSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Depression severity

Montgomery Asberg Depression Rating Scale (MADRS) Change

Time frame
6 weeks

Secondary outcomes

1

Depression severity

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

Time frame
up to 10 weeks
2

Depression severity

The Beck Depression Inventory (BDI-II) Change

Time frame
up to 10 weeks
3

Anxiety severity

General Anxiety Disorder-7 (GAD-7) Change

Time frame
up to 10 weeks
4

Suicidal ideation

The Beck Scale for Suicide Ideation (BSS) Change

Time frame
up to 10 weeks

Other outcomes

Sponsors and contacts

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

Centre for Addiction and Mental Health

Lead sponsor

Sunnybrook Health Sciences Centre

Collaborator

Source ClinicalTrials.gov
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