CYCLOSERINE for Major depressive disorder

Inclusion criteria

• {"criterion_text":"- A primary diagnosis of MDD, with a current moderate to severe depressive episode (score of >20 on the MADRS)"}
• {"criterion_text":"- Age between 18-65 years old"}
• {"criterion_text":"- A diagnosis of moderate to severe measures of treatment resistant depression (TRD) and have tried at least 2 types of antidepressant medication without sufficient result"}

Exclusion criteria

• {"criterion_text":"- Any change in antidepressant treatment (medication, psychotherapy) 4 weeks prior to enrollment"}
• {"criterion_text":"- Has a cochlear implant"}
• {"criterion_text":"- Metal implants near (<10 cm away from coil) the head including: - Aneurysm clips / coils - Any medical implant containing metal near the head - Metal stents in the brain - Shrapnel or bullet fragments - Implanted vagus nerve or deep brain stimulators, Electrodes for monitoring brain activity"}
• {"criterion_text":"- Pregnancy upon inclusion or during the study period, though women with childbearing potential will be included into the study."}
• {"criterion_text":"- Primary psychiatric diagnosis other than MDD"}
• {"criterion_text":"- A history of bipolar disorder"}
• {"criterion_text":"- A history of psychosis"}
• {"criterion_text":"- A history of schizophrenia"}
• {"criterion_text":"- A history of renal insufficiency"}
• {"criterion_text":"- Current substance abuse disorder"}
• {"criterion_text":"- Current scheduled use of benzodiazepines (as needed use is permitted, except for the day prior to treatment)"}
• {"criterion_text":"- Current use of any of the following medications: Olanzapine, clozapine, ethionamide, isoniazid"}

Primary endpoints

• {"endpoint_text":"- Percentage reduction from baseline MADRS score measured weekly for 6 weeks post-treatment","definition_or_measurement_approach":"Percentage reduction from baseline MADRS score measured weekly for 6 weeks post-treatment."}

Secondary endpoints

• {"endpoint_text":"- Percentage reduction from baseline MADRS-score at 6 months follow-up.","definition_or_measurement_approach":"Percentage reduction from baseline MADRS-score at 6 months follow-up."}
• {"endpoint_text":"- Clinical remission (defined as a MADRS-score of ≤8) and clinical response (defined as a reduction from baseline MADRS score of >50%) at 6 weeks follow-up.","definition_or_measurement_approach":"Clinical remission defined as MADRS ≤8; clinical response defined as >50% reduction from baseline MADRS at 6 weeks."}
• {"endpoint_text":"- Percentage reduction from baseline GAD-7-score measured weekly for the first 6 weeks post-treatment and monthly for the remainder of 6 months.","definition_or_measurement_approach":"Percentage reduction from baseline GAD-7 score measured weekly for first 6 weeks and then monthly up to 6 months."}
• {"endpoint_text":"- Percentage reduction from baseline PHQ-9-score measured weekly for the first 6 weeks post-treatment and monthly for the remainder of 6 months.","definition_or_measurement_approach":"Percentage reduction from baseline PHQ-9 score measured weekly for first 6 weeks and then monthly up to 6 months."}
• {"endpoint_text":"- Change in performance on the cognitive test battery at 1 week follow-up.","definition_or_measurement_approach":"Change in cognitive test battery performance assessed at 1 week post-treatment."}
• {"endpoint_text":"- Side effect questionnaire taken immediately after treatment.","definition_or_measurement_approach":"Adverse events/side effects recorded via questionnaire immediately post-treatment."}
• {"endpoint_text":"- EQ5D questionnaire taken at 6 weeks follow-up.","definition_or_measurement_approach":"Health-related quality of life assessed using EQ-5D at 6 weeks."}

Methods

• Recruitment arrangements document present (K1_Recruitment arrangements) — specific methods not extractable from CTIS metadata
• Flyer (K2_Recruitment material flyer_NL) — recruitment flyer in Dutch targeting potential participants in the Netherlands
• Website (K2_Recruitment material WebsiteNL) — website recruitment material in Dutch for the Netherlands

Netherlands

Earliest CTIS Part Ii Submission Date

30-04-2025

Latest Decision Or Authorization Date

02-06-2025

Processing Time Days

33

Number Of Sites

1

Number Of Participants

48

Primary sponsor

Full Name

Universiteit Maastricht

Organisation Type

Educational Institution

Country Of Registered Address

Netherlands

Third parties

• {"country":"Netherlands","full_name":"Maastricht University Medical Center (MUMC+)","duties_or_roles":"Source of monetary support (listed in sourceOfMonetarySupport)","organisation_type":"Hospital"}