Participants
arrhythmia, post-traumatic stress disorders, depression, psychotic disorders, borderline personality disorders, affective disorders, mental illness, headaches, cranioencephalic trauma, skin rash, Åsberg depression, unipolar depression, depressive disorders, alcohol dependency, bipolar depression, manic, panic disorders, dementia, DSM-5
INFECTIOUS DISEASES, DISORDERS, NEUROLOGICAL DISEASE, ARRHYTHMIA, HEART INSUFFICIENCY, RESPIRATORY INSUFFICIENCY, SYNDROME, ARTERIAL HYPERTENSION
Initially, between August 15th, 2016 and September 20th, 2017, 47 patients (20 female and 27 male participants; mean age: 45.30 ± 14.20) with depressive disorders were recruited from the inpatient unit “affective disorders” at the Central Institute of Mental Health, Mannheim for this pilot trial. The characteristics of the participants who completed the trial are presented in Table Characteristics of the participant groups.Values are expressed as mean (standard deviation).W0, first stimulation; W1, one week after first stimulation; W2, two weeks after first stimulation; W3, three weeks after first stimulation; ATHF, Antidepressant treatment history form; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, fifth version; MADRS, Montgomery–Åsberg depression rating scale; tDCS, Transcranial direct current stimulation.*Of the 47 patients included in the study, 40 completed the three-week treatment, and seven dropped out of the study before finishing the trial. Hence, data of 4 participants of the sham stimulation group and 3 of the tDCS are missing.**p-values are Bonferroni-corrected.Patients with psychotic disorders, post-traumatic stress disorders, panic disorders, and borderline personality disorders were excluded from the study. We also excluded pregnant female participants, participants with a conservatorship or legal guardianship, and patients who were unable to provide consent due to severe mental illness. Furthermore, patients who met the following criteria were excluded: those with metal implants or medical devices (e.g., cardiac pacemakers), those with illegal drug and alcohol dependency at the time of the study, those experiencing acute suicidal crisis, those with medical conditions that alter adrenal functions, those taking glucocorticoids or medications that alter heart rate and variability (such as beta-blockers), those with any type of arrhythmia, those meeting DSM-5 criteria for dementia syndrome, those with a past medical history of severe cranioencephalic trauma, those with any neurological disease, those with severe decompensated medical conditions (such as therapy-resistant arterial hypertension, heart insufficiency, or respiratory insufficiency), and those with neoplastic or infectious diseases of any kind.Of the 47 patients initially included in the study, 40 completed the three-week treatment, resulting in a dropout rate of 14.89%. One 20-year-old participant was interrupted on the third day of stimulation due to a newly identified skin rash on the scalp, and a 78-year-old participant was discharged from the inpatient ward, interrupting the trial on the seventh day. Three participants (ages 34, 48, and 53) were terminated from the trial before the first stimulation appointment due to new diagnostic assessments, resulting finally in exclusion. Additionally, one participant (age 38) left the study before the first stimulation appointment due to the onset of a manic phase. Lastly, one participant (age 27) withdrew from the pilot study due to post-stimulation headaches.Regarding medication, all 40 participants (35 participants with unipolar depression and 5 participants with bipolar depression) who completed the stimulation trial received direct current stimulation as an add-on therapy to guideline-compliant pharmacotherapy for depression. Among them, seven received monotherapy with an antidepressant agent (SSRI, SNRI, bupropion, and trazodone), 14 were treated with two antidepressants (SSRI + mirtazapine, SSRI + trazodone, bupropion + trazodone), and one with a combination of three antidepressants (bupropion + mirtazapine + trazodone). Six patients were prescribed an antidepressant plus augmentation therapy (such as aripiprazole, quetiapine, or lithium), and five received a combination of two antidepressants and augmentation therapy. One patient received a quadruple combination of three antidepressants and quetiapine, and two received a triple combination of lithium, quetiapine, and an antidepressant. Two patients received quetiapine monotherapy, and two received dual therapy with lithium and quetiapine. There were no significant differences between the two groups concerning pharmacotherapy (Cramer’s V = 0.70, p = 0.42).