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Search / Trial NCT06895863

COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant Depression

Launched by DANISH RESEARCH CENTRE FOR MAGNETIC RESONANCE · Mar 19, 2025

Trial Information

Current as of September 02, 2025

Recruiting

Keywords

Brain Circuit Therapy Major Depressive Disorder (Mdd) Transcranial Magnetic Stimulation (Tms) Intermittent Theta Burst Stimulation (I Tbs) Copenhagen Magnetic Personalized Accelerated Brain Circuit Therapy (Compact) Treatment Resistant Depression (Trd)

ClinConnect Summary

The CoMPACT trial is a study designed to test a new treatment for people who have not found relief from their depression through traditional medications. Specifically, it focuses on a technique called transcranial Magnetic Stimulation (TMS) that uses magnetic fields to stimulate certain areas of the brain. In this trial, 78 participants will be divided into three groups: one group will receive the real treatment aimed at a specific brain area, another group will receive the treatment aimed at a different brain area, and the last group will receive a sham treatment, which looks like the real one but doesn't have any active effect. The goal is to see if the real treatments can significantly reduce depression symptoms compared to the sham treatment while ensuring safety and comfort.

To be eligible for this trial, participants must be between 18 and 95 years old, have moderate to severe depression that has not improved with at least two different medications, and must have been experiencing their current depressive episode for at least two months. Participants can expect to attend 25 treatment sessions over five days, where they will receive either the real or sham treatment. The study will also involve brain scans and monitoring to better understand how this new treatment works and to help improve future therapies for depression. If you or a loved one are struggling with treatment-resistant depression, this trial might be an option worth considering.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age range between 18 and 95 years
  • 2. 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.
  • 3. Major Depression Inventory (self-rapport) score higher than 25.
  • 4. 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.
  • 5. Duration of the current episode must be longer than 2 months but shorter than 4 years, as judged by the investigator
  • Exclusion Criteria:
  • 1. History of neurologic disease affecting the brain, including dementia and epilepsy
  • 2. Schizophrenia or any other psychotic disorder except for psychotic depression
  • 3. Suicidal or psychotic symptoms making the transport of participants hazardous
  • 4. Any form of compulsory admission or treatment within the past three months
  • 5. Treatment with ECT in the current depressive episode
  • 6. Current harmful use or dependency of substances according to ICD-10 and interfering with outcome evaluation as judged by investigator's discretion.
  • 7. High risk of non-adherence as judged by investigators discretion.
  • 8. Medical and psychiatric conditions interfering with study outcome and safety as judged by investigator's discretion.
  • 9. Female participants of childbearing age must not be pregnant or breast feeding, and they must use contraception during the trial.
  • 10. One of the prime contra-indications for MRI, including severe claustrophobia
  • 11. 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
  • 12. Patients who do not wish to be informed about MRI or EEG findings, which may have clinical relevance.

About Danish Research Centre For Magnetic Resonance

The Danish Research Centre for Magnetic Resonance (DRCMR) is a leading institution dedicated to advancing the field of magnetic resonance imaging (MRI) and spectroscopy through innovative research and clinical applications. With a focus on enhancing diagnostic accuracy and treatment efficacy, DRCMR collaborates with academic and industry partners to explore novel MRI techniques and technologies. The center is committed to conducting rigorous clinical trials that contribute to the understanding of various medical conditions, fostering an environment of scientific excellence and translation of research findings into clinical practice for improved patient outcomes.

Locations

Hvidovre, , Denmark

Glostrup, , Denmark

Hilleroed, , Denmark

Patients applied

0 patients applied

Trial Officials

Hartwig Siebner, Professor

Principal Investigator

Danish Researach Centre for Magnetic Resonance

Poul Videbech, Professor

Principal Investigator

Center for Neuropsychiatric Depression Research, Mental health Center Glostrup

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported