BridgeMD
New treatment option for Treatment Resistant Depression
Official title COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant Depression
ClinicalTrials.gov ID: NCT06895863
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 95
You may be able to join if
- 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...
- Duration of the current episode must be longer than 2 months but shorter than 4 years, as judged by the investigator.
You likely can't join if
- 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Glostrup Municipality, Denmark
- Hilleroed, Denmark
- Hvidovre, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glostrup Municipality, Denmark; Hilleroed, Denmark; Hvidovre, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.