SYF71f612249cb44ee0bffce2968f5121d1Registry ID: 2025-521686-27-01|RecruitingPhase 2
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interventional
N/A
1 country
7
The primary objective of this trial is to evaluate the efficacy of adding a daily oral dose of 100 mg D-cycloserine for major depressive disorder (MDD) compared to placebo during a nine weekday long treatment course of aiTBS assessed as the difference between groups in changes in depressive symptoms in the following PICO Population: >18 years old, with a current depressive episode (Montgomery-Asberg Depression Rating Scale [MADRS]-score >19).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 18, 2025
Actual (reported)Between-group difference in change of blinded rater MADRS total score from baseline to Day 28 (21-35) after first treatment day (interview by blinded external rater via video consultation documented on item level in eCRF).
Change in observer rated depressive symptoms (MADRS) to treatment day 12 and 180 and Clinical Global Impression (CGI) at day 12, 28, and 180
Response and remission rates at all time points on observer (MADRS) and self-rated depressive symptoms Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)
Survival time to initiation of new antidepressant treatment, hospitalization or death during the whole study period (until day 180)
Change in score from baseline to Day 5, 12, 42, and 180 (end of study) self-rated depressive symptoms (QIDS-SR); Intensity in Suicidal Ideation from Columbia Suicide Severity Rating Scale (ISI-CSSR); anxiety symptoms, General Anxiety Disorder 7 (GAD-7); functioning, Sheehan Disability Scale (SDS); general health perception, EQ-5D-5L
Change in cognitive functioning (THINC-it); pre-attentive stimuli detection, Mismatch Negativity (MMN); frontal oxygenation (fNIRS); resting EEG measures including frequency spectra, microstates, and aperiodic activity.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
D-Cycloserine 100 mg
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
D-Cycloserine 100 mg
Named ingredient: Cycloserine
View registry recordSahlgrenska University Hospital-Vaestra Goetalandsregionen
Goteborg, 413 46, Sweden
Region Oerebro Laen
Orebro, 701 85, Sweden
Sjukhusen I Vaester-Vaestra Goetalandsregionen
Kungalv, 442 41, Sweden
Robert Bodén
First Submitted
June 18, 2025
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Adjunctive D-Cycloserine in Major Depressive Disorder
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Uppsala University Hospital
Uppsala, 751 85, Sweden
Region Stockholm – SLSO
Stockholm, 113 65, Sweden
Region Skane Skanes Universitetssjukhus
Lund, 222 42, Sweden
Region Skane Helsingborg Hospital
Helsingborg, 252 23, Sweden