AIDA-DEP - Accelerated Intermittent theta-burst stimulation with D-cycloserine Augmentation for DEPression - a multicenter, randomized, placebo-controlled, double-blind clinical trial

Trial details

Who runs it

Region Uppsala

Trial code

EU 2025-521686-27-01

Record updated

2026. június 15.

Original description

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).Read full original descriptionShow less

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).

Inclusion: The subject has given their written consent to participate in the trial; For female subjects of fertile age, adequate contraception should be used; Signed informed consent; Are at least 18 years old at the time of written informed consent; Are able to read, speak, and understand Swedish; Are able and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations; Are able to swallow capsules; Meet ICD-10 criteria for a diagnosis of a major depressive disorder and are currently experiencing a major depressive episode of at least a 30-day duration at the time of the screening; Have sustained moderate-severe depression symptoms at screening, as defined by a screening MADRS total score ≥ 20; Failure to achieve clinical response with at least one adequate trial of a first line antidepressant medication or psychotherapy; Unchanged antidepressant medications for 4 weeks prior to enrollment and the patient have no intention of changing medications during the first 28 days of the study.

Exclusion: Have intracardial lines (pacemaker or ICD) intracranial metallic implant; Currently receive electroconvulsive therapy (ECT); Have any physical or psychological symptom, medication or other relevant finding at Screening or Baseline, based on the clinical judgment of clinical/medical study personnel, that would make a participant unsuitable for the study; Meet ICD-10 criteria for schizophrenia spectrum or other psychotic disorders, including MDD with psychotic features (except substance/medication-induced or due to another medical condition), or Bipolar I Disorder, Bipolar II Disorder and bipolar disorder NOS, or a lifetime diagnosis of schizophrenia spectrum or other psychotic disorders; Meet ICD-10 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine & nicotine). Participants with a diagnosis of alcohol or drug use disorder within the past 3 months will be excluded; Have presence of any psychiatric condition or symptom judged by the PI (or designee) to be a more significant clinical problem than MDD for the participant; Have an allergy or intolerance to any of the materials contained in either drug product; Have an unstable medical condition; Have epilepsy; Have renal failure; Current pregnancy, or intend to become pregnant during the study or who are currently nursing; Have porphyria; Use bensodiazepines; Use dextrometorphan; Use memantine; Use ketamine.

EU CTIS 2025-521686-27-01