Using D-Cycloserine to Enhance Brain Stimulation for Depression

D-Cycloserine Augmentation of Intermittent Theta Burst Stimulation (iTBS) in Depression: A Multi-Site, Randomised, Placebo-Controlled Trial (COGENT)

This study is testing if the drug D-Cycloserine can make brain stimulation treatment work better for people with major depression.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Alfred (Academic / other)
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT05591677 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates whether the drug D-Cycloserine (DCS) can enhance the effects of Intermittent Theta Burst Stimulation (iTBS) in patients with Major Depressive Disorder (MDD). Participants will receive either 50mg or 100mg of DCS or a placebo before daily iTBS sessions over four weeks. The study aims to determine the effectiveness of DCS in improving depressive symptoms compared to iTBS alone, as well as assess the safety and tolerability of the drug. Clinical assessments will be conducted at various points throughout the treatment period to evaluate outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of major depressive episode and treatment-resistant depression.

Not a fit: Patients with unstable medical conditions, certain neurological disorders, or those currently using substances may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective treatment option for patients suffering from treatment-resistant depression.

How similar studies have performed: Previous studies have shown promising results with similar augmentation strategies in enhancing the effects of brain stimulation therapies.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Inability to provide informed consent.
* Medically unstable patients at the discretion of the investigator.
* Concomitant neurological disorder or a history of a seizure disorder.
* Participants who are pregnant.
* 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.

Where this trial is running

Melbourne, Victoria

• Monash Alfred Psychiatry Research Centre — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Principal investigator: Leo Chen, MBBS PhD FRANZCP — The Alfred
• Study coordinator: Kaila Bianco

Conditions Major Depressive Disorder