Dutch-Depression Outcome Trial Comparing 5 Day Multi Daily Neuronavigated Theta Burst Sessions With 6 Weeks rTMS

Launched by AMSTERDAM UMC, LOCATION VUMC · Jun 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method for people who have treatment-resistant depression, which means they haven't improved with two or more standard treatments. The trial compares a cutting-edge approach called the Stanford Neuromodulation Therapy (SNT) to a standard treatment known as 10 Hz rTMS. The SNT method involves multiple therapy sessions in just five days, using advanced techniques to precisely target the brain area involved in mood regulation. Researchers want to see if this method is not only more effective but also more cost-effective than the traditional approach, which takes six weeks.

To participate in the trial, individuals must be at least 18 years old, speak and understand Dutch, and have a diagnosis of depression that hasn’t improved despite previous treatments. Participants will receive either the SNT treatment or the standard rTMS over a specified period and will be monitored for changes in their depression levels, quality of life, and overall safety. The study aims to enroll 108 participants over three years, and anyone interested should discuss their eligibility with their healthcare provider.

Gender

ALL

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