Stepped Care aiTBS 2 Depression Study (Ghent) (aiTBS2-Ghent)

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    University Ghent
Updated on 30 January 2022
depressed mood
mood stabilizer
selective serotonin reuptake inhibitors
major depressive disorder
sham treatment
Accepts healthy volunteers


Antidepressant-free unipolar melancholic depressed patients (at least stage 2 treatment-resistant) will be selected by a certified psychiatrist, who will administer (semi-)structured clinical interviews. Because concomitant antidepressant treatment can confound outcome results, all patients will go through a medication washout before entering the study and they will be free from any antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the treatment protocol. Only habitual benzodiazepine agents will be allowed.

STEP 1: Patients will be treated with in total 20 accelerated intermittent Theta Burst Stimulation (aiTBS) sessions (3000 pulses/session) over the left dorsolateral prefrontal cortex, which will be spread over 4 days. On each stimulation day, a given patient will receive 5 sessions with a between-session delay of 15 minutes. Patients will be randomized to receive either the real aiTBS or sham treatment (first week). However, the sham group will receive real aiTBS treatment with 10 days' time interval. The investigators expect that real aiTBS treatment and not sham will result in a significant and clinical meaningful response.

STEP 2: To optimize treatment and reduce relapse following the iTBS treatment, in a stepped care approach, all patients then continue with cognitive control training (CCT) ten days later. This CCT consists of 20 sessions, spread over 4 weeks. Patients will be randomized to receive either real CCT or a control training. During this follow-up treatment, all patients will be prescribed antidepressant medication (SSRI) again. As iTBS treatment effects are known to decline over time, the investigators expect that combining aiTBS with a follow-up CCT therapy will stabilize the clinical effects over time compared to receiving the iTBS treatment alone.

For baseline comparisons, patients will be closely matched for gender and age with never-depressed, medication-free healthy volunteers. No volunteer will undergo treatment.

Condition Depressive Disorder, Major, Treatment Resistant Depression, Melancholia
Treatment SSRI, aiTBS, CCT
Clinical Study IdentifierNCT03288675
SponsorUniversity Ghent
Last Modified on30 January 2022


Yes No Not Sure

Inclusion Criteria

Antidepressant-free unipolar major depression with melancholic features
Not responding to at least two trials with an antidepressant
Aged between 18-65 years old

Exclusion Criteria

Depression with bipolar/psychotic features
Severe personality disorders
Active substance abuse/dependence within a year prior to inclusion
Pregnancy or without effective anticonception for the duration of the trial
ECT non-responder
No response to more than 9 antidepressants
Any neurological condition
Any implanted electronic device susceptible for magnetic field radiation (e.g. pacemaker)
Any implanted metal device in the head region
Current or past history of epilepsy
Neurosurgical interventions
Known allergic reaction to radiotracers or associated compounds
Healthy volunteers may be accepted as control subjects
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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