Accelerated brain circuit therapy for treatment resistant depression
The Copenhagen Magnetic Personalized Accelerated Brain Circuit Therapy (CoMPACT) Trial
This study is testing a new type of brain stimulation treatment for people with depression that hasn't improved with other therapies to see if it can help them feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Danish Research Centre for Magnetic Resonance Academic / other |
| Locations | 3 sites (Glostrup Municipality and 2 other locations) |
| Trial ID | NCT06895863 on ClinicalTrials.gov |
What this trial studies
The CoMPACT trial is a randomized double-blinded sham-controlled study designed to evaluate a novel accelerated and personalized transcranial Magnetic Stimulation (TMS) treatment for patients suffering from Treatment Resistant Depression (TRD). Participants will undergo 25 sessions of intermittent theta-burst stimulation (iTBS) over five consecutive days, with random assignment to either real or sham stimulation targeting specific brain regions. The study aims to assess the efficacy of this innovative approach in alleviating depression symptoms while ensuring safety and tolerability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 95 with moderate to severe major depressive disorder who have not responded to at least two different classes of antidepressant medications.
Not a fit: Patients with a history of neurological diseases, psychotic disorders, or those currently experiencing severe suicidal symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new effective treatment option for patients with treatment resistant depression.
How similar studies have performed: Previous studies have shown promising results with accelerated TMS protocols, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Age range between 18 and 95 years * In- or outpatients with a moderate to severe single episode or periodic MDD according to ICD-10, verified by a M.I.N.I. interview. * Major Depression Inventory (self-rapport) score higher than 25. * Lacking or insufficient effect of at least two drug trials from two distinct classes, e.g., SSRI, SNRI, TCA, or MAO-inhibitors, used in the current episode, with adequate dose and duration as judged by the investigator. * Duration of the current episode must be longer than 2 months but shorter than 4 years, as judged by the investigator. Exclusion criteria: * History of neurologic disease affecting the brain, including dementia and epilepsy * Schizophrenia or any other psychotic disorder except for psychotic depression * Head trauma causing more than 5 minutes loss of consciousness * Suicidal or psychotic symptoms making the transport of participants hazardous * Any form of compulsory admission or treatment within the past three months * Treatment with ECT in the current depressive episode * Non-responders to TBS treatment within the current episode * Current harmful use or dependency of substances according to ICD-10 and interfering with outcome evaluation as judged by investigator's discretion. * High risk of non-adherence as judged by investigators discretion * Medical and psychiatric conditions interfering with study outcome and safety as judged by investigator's discretion. * Female participants of childbearing age must not be pregnant or breast feeding, and they must use contraception during the trial. * One of the prime contra-indications for MRI, including severe claustrophobia (see Appendix 08.05) * One of the prime contra-indications for TMS and persons with electrically, magnetically, or mechanically activated implants or with metal or magnetic pieces in their head (see Appendix 08.04) * Patients who do not wish to be informed about MRI or EEG findings, which may have clinical relevance.
Where this trial is running
Glostrup Municipality and 2 other locations
- Centre of Neuropsychiatric Depression Research — Glostrup Municipality, Denmark (Recruiting)
- Mental Health Center North Zealand — Hilleroed, Denmark (Not_yet_recruiting)
- Danish Research Centre for Magnetic Resonance — Hvidovre, Denmark (Not_yet_recruiting)
Study contacts
- Principal investigator: Hartwig Siebner, Professor — Danish Researach Centre for Magnetic Resonance
- Study coordinator: Poul Videbech, Professor
- Email: poul.videbech@regionh.dk
- Phone: +4538640634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.