D-Cycloserine Augmentation of Intermittent Theta Burst Stimulation (iTBS) in Depression (COGENT)
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.
Timeline
- Start
- 2023-04-21
- Primary completion
- 2026-05-29
- Completion
- 2026-05-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cycloserine | Small molecule | 50 mg | Oral |
| Comparator | Cycloserine | Small molecule | 100 mg | Oral |