Comparing two types of brain stimulation for treatment resistant depression

Higher, Faster, Better: Is an Accelerated Intermittent Theta Burst Stimulation Protocol Compared to Standard 10 Hz Repetitive Transcranial Magnetic Stimulation, More (Cost-) Effective in Patients With Treatment-resistant Depression?

This study is testing a new type of brain stimulation treatment for people with depression who haven't found relief from other therapies to see if it works better than the standard treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Amsterdam UMC, location VUmc (other)
• Locations: 4 sites (Nijmegen, GL and 3 other locations)
• Trial ID: NCT05900271 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a current diagnosis of treatment resistant depression who have not responded to at least two different antidepressant treatments.

Not a fit: Patients with bipolar disorder or current psychotic disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from treatment resistant depression.

How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating a potential for high remission rates in treatment resistant depression.

Eligibility criteria

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 this trial is running

Nijmegen, GL and 3 other locations

• 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

Conditions: Treatment Resistant Depression, TMS, treatment resistant depression