💬In plain words
What the trial is, and whether it could suit you
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 s
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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