Depression is a prevalent and debilitating disorder. The most common treatments are antidepressant medications and talking therapies. However, for many individuals, these are not their treatment of choice. Furthermore, even following a full course of treatment with an antidepressant or talking therapy, over one third of patients continue to be unwell.
The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for major depression. The present research question is whether home-based tDCS is an effective treatment for major depression for adults with major depression.
Participants will be randomised to receive either a 10-week course of active tDCS treatment in addition to their standard care (Treatment as Usual), or to only receive Treatment as Usual. Participants will be followed up for 6-months after the start of the treatment began.
After the 6-month follow-up visit, all participants from both groups can choose to continue/start the tDCS treatment. There will be a final follow-up visit 3 months later (9 months from the original treatment start of the trial).
Adults aged 18 years or over
Current episode of depression based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (APA, 2013) for major depressive disorder (MDD) as assessed by structured clinical assessment, Mini-International Neuropsychiatric Interview (MINI) (Sheehan et al., 1998)
Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS
Either not taking antidepressant medication or taking a stable dose of antidepressant medication for at least 6 weeks before enrolment.
Significant suicide risk as measured by answering 'yes' to questions 4, 5 or 6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Screen (Posner et al., 2011)
Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM-5 criteria as assessed in MINI
Current daily use of medications that affect cortical excitability (e.g. benzodiazepines)
Current illicit drug use or heavy alcohol use with high risk of alcohol use disorder as measured by a score of 8 or more in Alcohol use disorders identification test consumption (AUDIT C) (Khadjesari et al., 2017; NICE, 2023)
Parallel
transcranial direct current stimulation (tDCS)
DeviceParticipants randomised to the tDCS treatment arm will use a tDCS device which is a headset with the anode positioned over left dorsolateral prefrontal cortex (DLPFC) and cathode over right DLPFC (EEG positions F3 and F4, respectively). Treatment protocol consists of 5 tDCS sessions per week for 3 weeks followed by 3 tDCS sessions per week for 7 weeks, for a total of 36 sessions in 10 weeks. tDCS stimulation is 2 mA for 30 minutes with gradual ramp up over 30 seconds at the start and end of each session.
Montgomery-Åsberg Depression Rating Scale (MADRS)
To evaluate tDCS clinical effectiveness as the difference in depressive symptom severity at end of 10-week treatment period between two treatment arms: those receiving treatment as usual (TAU) alone and those receiving TAU plus tDCS
Montgomery-Åsberg Depression Rating Scale (MADRS)
To evaluate tDCS clinical effectiveness as the difference in depressive symptom severity at end of 6 month follow-up period between two treatment arms: those receiving treatment as usual (TAU) alone and those receiving TAU plus tDCS
Hamilton Depression Rating Scale (HDRS)
To evaluate tDCS clinical effectiveness as the difference in depressive symptom severity at end of 10-week treatment period between two treatment arms: those receiving treatment as usual (TAU) alone and those receiving TAU plus tDCS
Hamilton Anxiety Rating Scale (HAMA)
To evaluate tDCS clinical effectiveness as the difference in anxiety symptom severity at end of 10-week treatment period between two treatment arms: those receiving treatment as usual (TAU) alone and those receiving TAU plus tDCS
Montgomery-Åsberg Depression Rating Scale-Self Report (MADRS-S)
To evaluate tDCS clinical effectiveness as the difference in depressive symptom severity at end of 10-week treatment period between two treatment arms: those receiving treatment as usual (TAU) alone and those receiving TAU plus tDCS
Click on the lead sponsor to view all of their trials.
King's College London
Lead sponsor
Nottinghamshire Healthcare NHS Trust
Collaborator
Cardiff and Vale University Health Board
Collaborator
Northumberland, Tyne and Wear NHS Foundation Trust
Collaborator
Northamptonshire Healthcare NHS Foundation Trust
Collaborator
South London and Maudsley NHS Foundation Trust
Collaborator
Southern Health NHS Foundation Trust
Collaborator
