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AIDA-DEP - Accelerated Intermittent theta-burst stimulation with D-cycloserine Augmentation for DEPression - a multicenter, randomized, placebo-controlled, double-blind clinical trial
EU CTIS ID: 2025-521686-27-01
What this study is testing
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).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Have intracardial lines (pacemaker or ICD) intracranial metallic implant
- Current pregnancy, or intend to become pregnant during the study or who are currently nursing.
- Currently receive electroconvulsive therapy (ECT)
- 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
See the full eligibility criteria
- 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.
- Have intracardial lines (pacemaker or ICD) intracranial metallic implant
- Current pregnancy, or intend to become pregnant during the study or who are currently nursing.
- Currently receive electroconvulsive therapy (ECT)
- 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 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
- 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
- Have porphyria
- Use bensodiazepines
- Use dextrometorphan
- Use memantine
- Use ketamine
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.