NCT05591677Active, not recruitingPhase 2
D-Cycloserine Augmentation of Intermittent Theta Burst Stimulation (iTBS) in Depression (COGENT)
D-Cycloserine Augmentation of Intermittent Theta Burst Stimulation (iTBS) in Depression: A Multi-Site, Randomised, Placebo-Controlled Trial (COGENT)
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 16 Oct 2022
- Start date
- 21 Apr 2023
- Primary completion date
- 29 May 2026
- Lead sponsor
- The Alfred
- Diseases
- Depression
- NCT number
- NCT05591677
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 180
- From 21 Apr 2023 to the primary completion date, 29 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant neurological disorder or a history of a seizure disorder.
Other illness
- Current substance use meeting DSM-5 criteria for substance use disorder.
- Per DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder or delusional disorder as assessed by the Mini-International Neuropsychiatric Interview (MINI) at the time of screening.
- Diagnosis of any other mental disorder that is the participant's primary diagnosis or main mental health syndrome of concern at the time of screening, which may significantly affect psychiatric status and assessed as likely to impact trial participation, in the clinical judgement of the investigator.
Other
- Inability to provide informed consent.
- Medically unstable patients at the discretion of the investigator.
- Participants who are pregnant.
Who the study is looking for
- Diagnosis of major depressive episode (MDE), in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder or bipolar affective disorder.
- 18 years or older in age.
- Treatment resistant depression at Stage II of the Thase and Rush classification.56
- Baseline Montgomery Åsberg Depression Rating Scale score of ≥ 20 (moderate-to-severe depression severity).57,58
- No increase or initiation of new antidepressant therapy in the four weeks prior to screening.
- Demonstrated capacity to give informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Alfred Psychiatry Research Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.