Stepped Care AiTBS 2 Depression Study (Ghent)

NACompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

October 5, 2017

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions
Depressive Disorder, MajorTreatment Resistant DepressionMelancholia
Interventions
DEVICE

aiTBS

In the active aiTBS arm, the patients will receive 100 cycli of thetaburst trains of 2s, separated by an inter-train-interval of 6 seconds, delivered on the left dorsolateral prefrontal cortex (DLPFC; i.e. 3000 pulses per session). On each stimulation day, a given patient will receive 5 sessions with a between-session interval of 15 minutes. The treatment protocol of in total 20 aiTBS sessions will be spread over 4 days (i.e. 60.000 pulses in total). The sham coil has been specifically developed to mimic the real one.

BEHAVIORAL

CCT

By training working memory processing, the CCT aims at modulating similar prefrontal cortex regions as being stimulated previously by aiTBS, namely the DLPFC. thereby possibly stabilizing clinical effects of aiTBS over time. In total 20 sessions of CCT vs. control training (of approximately 25 minutes per session), will be spread over a period of 4 weeks.

DRUG

SSRI

All patients will be prescribed antidepressant medication (SSRI) again when starting the CCT (vs. control training).

Trial Locations (1)

9000

University Hospital Ghent, Ghent

All Listed Sponsors
lead

University Hospital, Ghent

OTHER

NCT03288675 - Stepped Care AiTBS 2 Depression Study (Ghent) | Biotech Hunter | Biotech Hunter