Clinical Trial

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

Active, Not Recruiting Phase 2
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Record status
This record was last updated December 4, 2025 (before its estimated May 29, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to investigate if the drug D-Cycloserine (DCS) improves the antidepressant effects of Intermittent Theta Burst Stimulation (iTBS), a non-invasive brain stimulation therapy, in patients with Major Depressive Disorder (MDD). The main questions it aims to answer are: * Whether taking DCS prior to iTBS therapy will be more effective in improving depressive symptoms than iTBS therapy alone. * Compare the effect of DCS 100mg/day versus 50mg/day on depressive symptoms. * Test the safety and tolerability of DCS. Participants will take either 50mg DCS per day, 100mg DCS or placebo prior to each iTBS treatment session. iTBS treatment will be administered daily, 5 days a week for 4 weeks. Clinical measures will be conducted at baseline and at the ends of weeks 1, 2, 3 and 4 of treatment.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-10-20; most recent amendment 2025-11-27.
Status change: Recruiting → Active, Not Recruiting 2025-11-27
Status change: Not Yet Recruiting → Recruiting 2022-12-29
Trial Details
NCT Number NCT05591677
Lead Sponsor The Alfred
Collaborators: Blue Bell Health, Australia, Gold Coast Hospital and Health Service
Conditions Major Depressive Disorder
Enrollment 180 participants
Start Date 2023-04-21
Primary Completion 2026-05-29 (estimated)
Study Completion 2026-05-29 (estimated)
Updated on ClinicalTrials.gov 2025-12-04