Accelerated brain circuit therapy for treatment resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CoMPACT trial is a randomized double-blinded sham-controlled study designed to evaluate a novel accelerated and personalized transcranial Magnetic Stimulation (TMS) treatment for patients suffering from Treatment Resistant Depression (TRD). Participants will undergo 25 sessions of intermittent theta-burst stimulation (iTBS) over five consecutive days, with random assignment to either real or sham stimulation targeting specific brain regions. The study aims to assess the efficacy of this innovative approach in alleviating depression symptoms while ensuring safety and tolerability.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre of Neuropsychiatric Depression Research
  Glostrup Municipality, Denmark Recruiting
• Mental Health Center North Zealand
  Hilleroed, Denmark Not yet recruiting
• Danish Research Centre for Magnetic Resonance
  Hvidovre, Denmark Not yet recruiting

Study contacts

• Principal investigator: Hartwig Siebner, Professor — Danish Researach Centre for Magnetic Resonance
• Study coordinator: Poul Videbech, Professor
• Email: poul.videbech@regionh.dk
• Phone: +4538640634

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• EEG-Guided TMS for Adults With Depression

  This study tests whether delivering intermittent theta burst stimulation (iTBS) timed to brain waves using EEG can improve treatment for adults with major depressive disorder who have not responded to usual antidepressants.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07862205

• Ketamine plus behavioral activation therapy for treatment-resistant depression

  This study tests whether adding behavioral activation therapy to ketamine treatment helps adults with treatment-resistant depression feel better than ketamine alone.

  Recruiting Phase 2/3 The Royal's Institute of Mental Health Research · Ottawa, Ontario · NCT07801703

• Ketamine-assisted psychotherapy for treatment-resistant depression in adults

  This open-label program tests intravenous ketamine combined with psychotherapy to see if it helps adults with treatment-resistant depression.

  Recruiting Senz · Doorn, Utrecht · NCT07706478

• Mindfulness‑augmented brain stimulation for treatment‑resistant depression

  This trial will test whether combining fast brain stimulation (iTBS) with a digital mindfulness program helps people with treatment‑resistant depression reduce symptoms and improve thinking.

  Recruiting Phase 2 University of California, San Diego · San Diego, California · NCT07512284

• ipRGCs as biomarkers to predict TMS response in major depressive disorder

  This study tests whether retinal cells called ipRGCs can predict who will respond to TMS in treatment-resistant depression.

  Recruiting Polytechnic Institute of Porto · Porto, Porto District · NCT07474974

• Rapid, robot-guided TMS with NRX-101 for treatment-resistant depression

  This trial tests whether a single-day, robot-guided brain stimulation plus NRX-101 can help adults with treatment-resistant depression compare to sham stimulation and placebo.

  Recruiting at 3 sites Phase 2/3 NeuroRx, Inc. · Sarasota, Florida and 2 other locations · NCT07227103

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.