Actively Recruiting
COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant Depression
Led by Danish Research Centre for Magnetic Resonance · Updated on 2026-01-22
78
Participants Needed
3
Research Sites
189 weeks
Total Duration
On this page
Sponsors
D
Danish Research Centre for Magnetic Resonance
Lead Sponsor
G
Glostrup University Hospital, Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 Treatment Resistant Depression (TRD). CoMPACT consists of 25 sessions of intermittent theta-burst transcranial stimulation (iTBS) consisting of high inter-pulse frequency administered five times daily over five consecutive days. The trial will include 78 patients with TRD who will be randomly assigned to one of three groups: * Group 1: Real CoMPACT targeting the left dorsolateral prefrontal cortex (DLPFC). * Group 2: Real CoMPACT targeting a novel site, the left inferior parietal lobule (IPL). * Group 3: Sham CoMPACT targeting the left DLPFC (50%, Group 3a) or left IPL (50%, Group 3b). The hypothesis is that real prefrontal or parietal CoMPACT targeting will significantly alleviate depression symptoms compared to sham targeting, without compromising safety, feasibility, or tolerability. The trial incorporates a personalized approach, using electrical field (E-field) modeling based on individual structural brain scans to tailor and standardize iTBS, ensuring accurate targeting of cortical volume and consistent induced electrical field strength. To delineate the treatment mechanism of action at the brain network level, multi brain mapping models will be implemented. Electroencephalography (EEG) records of spontaneous and TMS-evoked electrical brain activity will be obtained before, during, and after iTBS sessions to understand how the high frequency burst protocol functionally engages the stimulated cortex. Structural and functional brain MRI before and after the treatment will be used to study changes in depression-related brain networks. This will offer key insights into how CoMPACT affects depression-related brain networks and may identify neuroimaging markers for predicting treatment response, and thus informing future TBS treatments for TRD.
CONDITIONS
Official Title
COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 95 years
- Patients with moderate to severe single episode or periodic major depressive disorder (MDD) according to ICD-10, verified by M.I.N.I. interview
- Major Depression Inventory score higher than 25
- Insufficient effect of at least two drug trials from two different antidepressant classes during current episode
- Current depressive episode duration longer than 2 months but shorter than 4 years
You will not qualify if you...
- History of neurological diseases affecting the brain, including dementia and epilepsy
- Diagnosis of schizophrenia or other psychotic disorders except psychotic depression
- Head trauma causing loss of consciousness over 5 minutes
- Suicidal or psychotic symptoms that make transport unsafe
- Compulsory admission or treatment within past three months
- Treatment with electroconvulsive therapy in current episode
- Non-response to theta-burst stimulation during current episode
- Current harmful use or dependency of substances interfering with outcome
- High risk of non-adherence as judged by investigators
- Medical or psychiatric conditions interfering with safety or study outcome
- Female participants of childbearing age must not be pregnant or breastfeeding and must use contraception during trial
- Contraindications for MRI, including severe claustrophobia
- Contraindications for TMS or presence of electrical, magnetic or metallic implants in the head
- Patients unwilling to be informed about clinically relevant MRI or EEG findings
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Centre of Neuropsychiatric Depression Research
Glostrup Municipality, Denmark, 2600
Actively Recruiting
2
Mental Health Center North Zealand
Hilleroed, Denmark, 3400
Not Yet Recruiting
3
Danish Research Centre for Magnetic Resonance
Hvidovre, Denmark, 2650
Not Yet Recruiting
Research Team
P
Poul Videbech, Professor
CONTACT
I
Iman Ibrahim, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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