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Home trial

Overview

What is the study about?
Major depression is a common and disabling. Currently the most common treatments are antidepressant medications and talking therapies. However, after a full course of either treatment, over one third continue to be unwell. As well, for many individuals, they would prefer to not take antidepressant medications or be involved in talking therapy.
Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation, and studies have shown that tDCS could be a possible treatment for major depression. tDCS produces a small electric current (2 mA) which affects how easily brain cells can discharge. The tDCS device is a headset with two metal discs, called electrodes, that sit on the top part of the forehead. One is for where the current is generated and one for where the current goes back to the device.
In this study we want to build on from our previous research to see how effective tDCS is for the treatment of major depression.
What is the purpose of the study?
We recently completed a study with 174 participants with major depression. We found that participants who received the active tDCS sessions showed a greater improvement in their depressive symptoms as compared to participants who had the inactive tDCS sessions. The tDCS device was the same for both groups, but one was active and the other one was inactive, and all sessions were at home.
We want to see how effective the tDCS treatment is when compared with usual treatments. All sessions can be provided at home.
What does participation involve?
We are looking for 438 individuals with major depression to take part in our HOME trial.
Using a random allocation process, half of the participants will be offered the tDCS sessions for 10 weeks, as well as continuing their usual treatment, and half will continue their usual treatment.
All participants will have some initial telephone and video calls to talk about the study and to ask about your health.
If you take part in the study, there will be 5 study visits over 10 weeks, and three follow up study visits after 4, 6 and 9 months. The study visits will involve going through assessments and questionnaires and checking how you are.
For people who are randomised to receive the tDCS treatment, this will involve having 5 sessions per week for the first 3 weeks and then 3 sessions per week for 7 weeks. Each session is 30 minutes. We will show you how to use the tDCS device and we will help you to learn how to use the device by yourself at home.
After the 6-month follow up visit, everyone in the trial will be able to use the active tDCS device if they would like and participants who have not had a tDCS device will receive one.
What is the possible benefit of taking part?
tDCS has been shown to improve depressive symptoms in people with major depression. Your participation will help our understanding of tDCS as a possible. You will be reimbursed £20 in vouchers for each study visit that you attend after enrolment. This is a total of £160 in vouchers for all study visits. Additionally, you will be able to keep the tDCS device after the study.
Am I eligible to take part?
To be considered for the study, you will need to meet the following eligibility criteria:
  • Aged 18 years of older;
  • Having a diagnosis of major depressive disorder;
  • Not having a primary diagnosis of another mental health disorder;
  • Currently not experiencing active suicidal thoughts;
  • Have not tried brain stimulation, es/ketamine or psychosurgery for the treatment of depression;
  • Not having a neurological disorder or cognitive impairment;
  • Recently not involved in alcohol and substance abuse
  • Not currently pregnant
  • Do not have an implant in the brain, a neurocranial defect, shrapnel or any ferromagnetic material in the head, nor any active implantable medical device;
  • Are not currently participating in another interventional study

Interested in taking part in this study? Fill out this form.

Planned end date

31 Dec 2027 11:14

Conditions

Depression

Inclusion Criteria

  1. Adults aged 18 years or over
  2. 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)
  3. Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS
  4. Being medication free or taking stable antidepressant medication or in psychotherapy for at least 6 weeks before enrolment
  5. Being under the care of GP and / or community mental health services
  6. Agreeable for GP to be regularly informed by about study participation
  7. Able to provide written, informed consent

Exclusion Criteria

  1. 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)
  2. Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM-5 criteria as assessed in MINI
  3. Current daily use of medications that affect cortical excitability (e.g. benzodiazepines)
  4. Current illicit drug use or heavy alcohol use with high risk of alcohol use disorder as measured by a score of >=8 in Alcohol use disorders identification test consumption (AUDIT C) (Khadlesari et al., 2017; NICE, 2023)
  5. History of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation
  6. History of esketamine / ketamine for treatment of depression
  7. History of psychosurgery for depression
  8. Having cognitive impairment (e.g. dementia)
  9. Current medical disorder or neurological disorder that may mimic mood disorder (e.g. hormonal disorder, unstable heart disease)
  10. Have any implant in the brain or neurocranial defect
  11. Have shrapnel or any ferromagnetic material in the head
  12. Have any active implantable medical device (e.g. pacemaker)
  13. Currently pregnant
  14. Concurrent enrolment in another interventional study
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