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

Prior treatment

• 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

Other illness

• 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

Other

• 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

• 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.