Status:
RECRUITING
COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant Depression
Lead Sponsor:
Danish Research Centre for Magnetic Resonance
Collaborating Sponsors:
Center for Neuropsychiatric Depression Research (CNDR), Mental Health Centre Glostrup
Mental Health Center North Zealand
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
18-95 years
Phase:
NA
Brief Summary
The CoMPACT trial is a randomized double-blinded sham-controlled study aimed at testing a novel accelerated and personalized transcranial Magnetic Stimulation (TMS) treatment for patients with Treatme...
Detailed Description
Repetitive TMS (rTMS) of left DLPFC was approved by the US Food and Drug Administration (FDA) in 2008 as a therapy TRD, and this was extended to the equally effective iTBS protocol in 2018. Dysfuncti...
Eligibility Criteria
Inclusion
- 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
- History of neurologic disease affecting the brain, including dementia and epilepsy
- Schizophrenia or any other psychotic disorder except for psychotic depression
- 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
- 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
- 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
- Patients who do not wish to be informed about MRI or EEG findings, which may have clinical relevance.
Key Trial Info
Start Date :
January 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06895863
Start Date
January 15 2025
End Date
September 1 2028
Last Update
March 26 2025
Active Locations (3)
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1
Centre of Neuropsychiatric Depression Research
Glostrup Municipality, Denmark, 2600
2
Mental Health Center North Zealand
Hilleroed, Denmark, 3400
3
Danish Research Centre for Magnetic Resonance
Hvidovre, Denmark, 2650