Comparing two types of brain stimulation 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

This clinical trial aims to evaluate the effectiveness and cost-effectiveness of a novel treatment protocol called Stanford Neuromodulation Therapy (SNT), which utilizes intermittent Theta Burst Stimulation (iTBS) delivered multiple times a day over five days, compared to the standard 10 Hz repetitive Transcranial Magnetic Stimulation (rTMS). The study will involve patients diagnosed with treatment resistant depression who have not responded to at least two prior evidence-based treatments. Participants will be randomly assigned to receive either the SNT protocol or the standard rTMS treatment, with the goal of determining which approach leads to higher remission rates. The study will also assess the overall cost-effectiveness of the two treatment methods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 years of age or older;
* Sufficient level of spoken and written Dutch;
* Ability to freely provide written informed consent;
* Current DSM-5 diagnosis of a depressive episode, ascertained by the Mini International Neuropsychiatry Interview (MINI-S).
* A Hamilton depression rating score (HDRS) of \>16 points: this score will be obtained from the SIGH-ADS, a depression rating scale able to determine the HDRS score and a score for atypical depression.
* have a treatment resistant depression, defined according to the criteria of Conway, that is, lack of remission for eight consecutive weeks after two different evidence-based treatments anti-depressant medication has to be adequately dosed(7,24).
* Stable anti-depressant medication 6 weeks prior to study. Benzodiazepines may be used up to a dosage equivalent of 3.0 mg lorazepam, and can be lowered over time during the study based on clinical judgement.

Exclusion Criteria:

* \- Bipolar disorder.
* Current psychotic disorder¸ including psychotic depression, assessed by treating psychiatrist.
* Suspected dementia, assessed with a dementia screening tool, i.e., the Montreal Cognitive Assessment (MOCA)(25), with a score of less than 20 points, or a clinical suspicion of dementia, or neuroimaging indication for neurodegeneration with a Fazekas \> 1 and MTA \>1. These cut-offs ensure exclusion of patients with (preclinical) dementia.
* Active suicidal thoughts and intent to act on it, assessed at the baseline interview and before the start of the trial. This assessment is based on the Columbia suicide severity rating scale, i.e., question 5 is answered positive "Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan?" (26).
* Metallic devices implanted above the neck, assessed at the baseline interview.
* Patients diagnosed with epilepsy, by a neurologist, assessed at the baseline interview.
* Substance abuse 4 weeks prior to the study, including high dosage of benzodiazepine, a dosage equivalent higher than 3.0 mg lorazepam, assessed at the baseline interview.
* Inability to understand or comply with study requirements as judged by the investigators, assessed at the baseline interview.
* Pregnancy

Where it's running

• Radboud UMC
  Nijmegen, Gl, Netherlands Recruiting
• GGZinGeest
  Amsterdam, North Holland, Netherlands Recruiting
• Amsterdam UMC location AMC
  Amsterdam-Zuidoost, North Holland, Netherlands Recruiting
• Maastricht UMC
  Maastricht, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Annemiek Dols, MD PhD
• Email: a.dols@amsterdamumc.nl
• Phone: 0610445878

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.

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• 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.