Repetitive transcranial magnetic stimulation (rTMS) is an evidence-based treatment option for major depressive disorder (MDD). However, comparisons of efficacy between the two FDA-approved protocols ...of rTMS modalities are lacking. The aim of this industry-independent, randomized-controlled, single-blind trial was to evaluate clinical outcome of the two FDA-approved rTMS protocols delivered by H1-coil and the figure-8-coil, in MDD patients. A total of 228 MDD patients were randomized to 20 sessions of H1-coil or 8-coil as an adjunct to standard-of-care pharmacotherapy, or standard-of-care pharmacotherapy alone. Baseline MDD symptom severity was almost the same in the three groups. Hamilton depression rating scale (HAM-D17) mean score was 17 (5.3) in H1-coil, 17 (5.4) in 8-coil, and 19 (6.1) in control group. The primary outcome was the proportion of patients achieving remission defined as HAM-D17 score ≤7 at end-of-treatment at week-4. In the intention-to-treat analysis odds ratio for remission was 1.74 (CI95% 0.79–3.83) in H1-coil compared to the 8-coil group. The difference between two rTMS protocols was not significant. Remission rate was significantly greater in both HF-rTMS groups compared to the control: 60% (CI95% 48–71%), 43% (CI95% 31–55%) and 11% (CI95% 5–20%) respectively. The response was significantly better in H1-coil, than in 8-coil group OR = 2.33; CI95% 1.04–5.21 (P = 0.040). The HAM-D17 was lowered by 59% in the H1-coil, 41% in the 8-coil (P = 0.048), and 17% in the control group (P < 0.001 vs H1-coil; P = 0.003 vs 8-coil). Safety, tolerability, and the changes in quality of life were comparable. We confirmed the safety and efficacy of both FDA-approved protocols as adjunctive treatments of MDD. Better response rate and greater reduction of depression severity were observed in the H1-coil group, but without a significant difference in the remission rate between the two rTMS modalities.
Clinicaltrials.govNCT02917499
•Remission rate was significantly greater in HF-rTMS groups compared to the control.•Main-analyses showed no difference in remission rate between H1-coil, and 8-coil group.•Better response rate and reduction of depression severity was observed in H1-coil, than in 8-coil group.•Both rTMS modalities ware equally safe and well tolerated.
To assess the efficacy of repetitive transcranial magnetic stimulation (rTMS) with an H1 coil as a treatment for hopelessness in patients with major depressive disorder (MDD).
We conducted a ...randomised controlled trial in a tertiary psychiatric institution in Croatia, including patients diagnosed with MDD without psychotic symptoms and with clinically relevant hopelessness. High-frequency (18 Hz) rTMS with an H1 coil was administered over four weeks on the left dorsolateral prefrontal cortex. We examined changes in the Beck Hopelessness Scale (BHS) scores.
We randomly assigned 51 participants to the intervention group (rTMS plus standard therapy) and 52 to the control group (standard therapy). The mean (
) ages were 50 (12.3) and 50 (10.4) years, and 47% and 52% of the participants were females in the intervention and control groups, respectively. Following treatment, the BHS scores decreased (unadjusted bivariate analysis,
= 0.043; false discovery rate (FDR) >5%). Multivariate analysis revealed that the BHS score was reduced by 10.8% (95% confidence interval (CI: -17.8% to -3.9%) in the rTMS group and 0.7% (95% CI: 7.5% -6.1%) in the control group (
= 0.037; FDR < 5%).
rTMS with an H1 coil improved the symptoms of hopelessness in patients with MDD.
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique with few side effects that has been reported to be effective in the treatment of major depressive disorder (MDD). At ...present, no randomized controlled trials (RCT) have compared the efficacy and safety of rTMS delivered by the figure-8-coil and the H1-coil. We describe an industry-independent, randomized, controlled, single-blinded, single-center study protocol assessing the differences in efficacy and safety of rTMS for patients diagnosed with MDD with the H1-coil and figure-8-coil as an add-on to stable pharmacotherapy or pharmacotherapy alone. Stimulation protocols follow those that led to the FDA clearance of these treatments for MDD. The sample of 76 patents in each of the three groups will be enrolled and assessed with clinical and neuropsychological tests. The primary outcome is remission rate defined as Hamilton depression rating scale (HAM-D17) score ≤7 at the end of week-4. This clinical trial will address the efficacy and safety of rTMS modalities for MDD. The evaluation of biological markers will also help to elucidate the pathophysiology of MDD and the mechanisms of action of rTMS.
This article reviews the history, evolution, and current status of repetitive transcranial magnetic stimulation (rTMS) in Croatia. University Psychiatric Hospital Sveti Ivan experts performed the ...first rTMS in 2015 as a first treatment and research group in Croatia. In addition to being a leading center for rTMS in clinical trials and in treating depression, University Psychiatric Clinic Sveti Ivan TMS center continues to research rTMS for depression and other neuropsychiatric disorders and conditions, exploring novel stimulation parameters and individualized treatment protocols. Since 2017 rTMS treatment for MDD in Croatia has been reimbursed by the National Insurance Fund and has been available to hospital and ambulatory patients by indication, and now is widely used in other health centers in Croatia, to treat depression and other neuropsychiatric disorders and conditions, especially when drugs are ineffective or produce harmful side effects.
This brief report presents the studies on HF rTMS efficacy on major depressive disorder (MDD) symptoms conducted in University Psychiatric Hospital Sveti Ivan from 2016 to 2022. We assessed the ...clinically relevant effects of rTMS delivered by H1-coil and the figure-8-coil on MDD symptoms severity in the pooled sample of patients. During the last seven years, we enrolled in the studies on MDD 336 patients with a median (interquartile range; IQR) age of 53 (45-61) years, 181 (54%) of them women. We performed interventions with two different coils (8-coil and H1-coil) at 120% of the motor threshold, approximately half with 10 and half with 18 Hz frequency, and > 90% with one daily session during 20 workdays. We offer considerations on how the bulk of our research informed the future direction of our laboratory's studies and clinical work.
Abstract
Background
The links between schizophrenia (SCH) or major depressive disorder (MDD) and chronic physical multimorbidities (CPM) are well established. Patients diagnosed with these disorders ...have a higher prevalence of CPM than the general population (GEP). However, our knowledge of age and gender determined differences in the development of CPM between SCH, MDD, and GEP remains fragmented and inconsistent. This exploratory study intended to compare the onset of CPM in female and male SCH and MDD patients, and the general population (GEP).
Methods
This nested, single-centered, cross-sectional study was performed during 2016 at Psychiatric hospital Sveti Ivan, Zagreb-Croatia. Data were collected for a consecutive sample of 136 patients diagnosed with SCH, 290 diagnosed with MDD, and 861 participants from the general population of the city of Zagreb and Zagreb County. The primary outcome was the prevalence of CPM. The secondary outcome was the prevalence of CPM in the youngest age group ≤35 years.
Results
After adjustment for gender and education, the prevalence of CPM was significantly different between patients with SCH or MDD and GEP (p<0.001). In the oldest age group (≥65 years) the difference was not significant anymore. In the youngest age group, the prevalence was highest in SCH patients (33%) followed by MDD (26%) and GEP (15%) indicating the early onset of CPM in severe mental illness. In the male participants <35 years old, there were no significant differences in the prevalence of CPM between SCH (25%), MDD (23%) and GEP (15%) (p=0.411). However, in the female participants <35 years old the difference was significant and clinically relevant (p=0.006). Prevalence of CPM in female participants was 50% in SCH, 33% in MDD and 14% in GEP.
Discussion
This study finding indicated the earlier onset of CPM in SCH and MDD patients than in GEP. This difference is primarily caused by the high prevalence of CPM in young female patients diagnosed with SCH. More prevalent physical morbidity points to a substantial disadvantage of female SCH patients early in the course of the illness. Understanding the nature and biological basis regarding the risk and outcome of CPM might help to identify new therapeutic targets, allow more individualized treatment, and facilitate better risk prediction and application of healthcare resources.
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