D-Cycloserine Augmentation of Intermittent Theta Burst Stimulation (iTBS) in Depression (COGENT)

PHASE2RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

April 21, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Major Depressive Disorder
Interventions
DRUG

D-Cycloserine

D-cycloserine (DCS) is a partial NMDA receptor agonist that has demonstrable impact on rTMS and TBS's neuromodulatory effects. Participants will be asked to orally ingest one capsule 2-hours prior to their scheduled iTBS treatment time.

DEVICE

Intermittent Theta Burst Stimulation

Intermittent Theta Burst Stimulation (iTBS) will be administered with a magnetic stimulator using a figure-of-8 coil or equivalent FDA-approved device. Initial treatment coil localisation and individual calibration of stimulation intensity will be conducted by TMS-trained investigators/staff using standard approaches.67,68 Stimulation intensity will be at 90% of the individual's calibrated resting motor threshold. iTBS treatment session delivers 600 pulses and is approximately 3½ minutes in duration. The total pulse number applied over a course of 20 treatments will be 12,000. This regimen is analogous with the iTBS protocol approved by the US FDA to treat TRD.

Trial Locations (1)

3004

RECRUITING

Monash Alfred Psychiatry Research Centre, Melbourne

All Listed Sponsors
collaborator

Blue Bell Health, Australia

UNKNOWN

collaborator

Gold Coast Hospital and Health Service

OTHER_GOV

lead

The Alfred

OTHER