Trial results for a study investigating the effect of transcranial direct current stimulation (tDCS) on depressed patients were posted on ClinicalTrials.gov on 2025-09-11. The study enrolled 198 participants.
Background
Depression is a common and serious medical illness that negatively affects how a person feels, thinks, and acts. It can lead to a variety of emotional and physical problems and can decrease a person's ability to function at work and at home. Current treatments include psychotherapy, medication, and other brain stimulation therapies. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that delivers a low-level electrical current to specific areas of the brain. This study aimed to demonstrate the effectiveness of tDCS in the clinical domain for patients with depression and to optimize home-based e-medication technology.
Trial design
This completed study, designated as Phase NA, enrolled 198 participants with Depression. The trial investigated the effectiveness of transcranial direct current stimulation (tDCS). Participants were assigned to either an "Active (Real)" tDCS group or a "Sham" (placebo) group to compare outcomes.
Key results
The trial reported several key measurements and analyses regarding changes in depressive symptoms at Week 13:
- Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13:
- For the Active (Real) group, the mean change was 30.27 (Standard Deviation 13.22 units on a scale).
- For the Sham group, the mean change was 29.62 (Standard Deviation 11.12 units on a scale).
- For the Active (Real) group, the mean change was 24.96 (Standard Deviation 13.01 units on a scale).
- For the Sham group, the mean change was 23.98 (Standard Deviation 13.32 units on a scale).
- For the Active (Real) group, the mean change was 24.35 (Standard Deviation 13.85 units on a scale).
- For the Sham group, the mean change was 22.09 (Standard Deviation 13.66 units on a scale).
- For the Active (Real) group, the mean change was 22.81 (Standard Deviation 14.9 units on a scale).
- For the Sham group, the mean change was 20.49 (Standard Deviation 14.46 units on a scale).
- Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13:
- For the Active (Real) group, the mean change was 25.63 (Standard Deviation 8.15 units on a scale).
- For the Sham group, the mean change was 24.29 (Standard Deviation 7.71 units on a scale).
- For the Active (Real) group, the mean change was 19.76 (Standard Deviation 8.40 units on a scale).
- For the Sham group, the mean change was 19.43 (Standard Deviation 8.79 units on a scale).
Key analyses performed on the trial data included:
- Mixed Models Analysis yielded p-values of 0.862 and 0.662.
- ANOVA yielded p-values of 0.318, 0.273, 0.639, and 0.452.
What this means
The posted trial results indicate that there was no statistically significant difference in the reduction of depressive symptoms between the active transcranial direct current stimulation (tDCS) group and the sham group at Week 13, as evidenced by p-values consistently above 0.05 across various analyses. This suggests that the active tDCS intervention, as implemented in this study, did not demonstrate a superior effect compared to the sham treatment for patients with depression based on the BDI-II and MADRS scales.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05539131, titled "Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) on Depressed Patients", were posted on 2025-09-11 on clinicaltrials.gov.