depression mood disorder
Conditions
Interventions
Intervention: 50 sessions using the SNT protocol in 5 days. We will target the
region of the left DLPFC most anticorrelated with the subgenual anterior
cingulate cortex (sgACC) in each participant b
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult patients with unipolar depression who did not respond to two or more evidence-based treatments for depression, in the current depressive episode, aged 18 years and over. In order to be eligible to participate in this study, a participant must meet all following 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 - 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. - 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
Exclusion criteria: Participants meeting any of the following criteria will be excluded from participation in this study - Bipolar disorder. - Current psychotic disorder* including psychotic depression, assessed by treating psychiatrist. - Suspected dementia, assessed with a dementia screening tool, i.e.i.e., the Montreal Cognitive Assessment (MOCA)(31), 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.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?* (32). - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical outcome is remission, which is defined as a score of 7 or lower on the clinician-rated HDRS-17 (Hamilton Depression rating Scale) measured directly after the last treatment session. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Health-related quality of life determined with the EuroQol-5D13 and Health care usage/costs, patients' and their family's out-of-pocket costs, and productivity losses owing to absenteeism measured with the Trimbos Institute and iMTA Cost questionnaire for Psychiatry (14). 2) Patient-reported outcome measures, i.e., positive mental health as measured with Mental Health Continuum-Short Form (15). 3) Percentual reduction of depressive symptoms as measured with self-rated HDRS-6 on each treatment day. 4) Relapse, at 5-, 10- and 25-weeks post-treatment. Relapse is defined as a HDRS-17 total score of 15 or higher for 2 consecutive assessments separated by 5 to 15 days or hospitalization for depression 5) Tolerability and safety of SNT and rTMS. 6) Factors that influence the implementation of SNT that are healthcare system-, clinician- or patient- related, in order to develop an implementation plan. | — |
Countries
Netherlands
Outcome results
None listed