Major Depressive Disorder
Conditions
Brief summary
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 tDCS can be provided as a home-based treatment for major depression for adults with major depression.
Detailed description
The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for major depression. tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are two electrodes, which are small metal discs, where the current comes from. tDCS does not directly stimulate brain cells to cause a seizure like electroconvulsive therapy (ECT) and it does not induce brain cells to discharge like transcranial magnetic stimulation (TMS). Clinical studies have shown that tDCS treatment could help to improve the symptoms of depression. The main side effects have been redness, skin irritation or sensations (itching, tingling or burning) under the electrodes. Less commonly reported side effects include headache or tiredness. tDCS is a portable and safe treatment. The studies to date have mostly looked at tDCS treatment which has been provided in a research setting. This is a problem because the treatment requires daily sessions for several weeks which could limit whether individuals would be able to go every day. As tDCS is a portable and safe treatment, it could be provided in the community. The study research question is whether tDCS could be provided as a home-based treatment for major depression. The study will include adults with major depression.
Interventions
DEVICEtranscranial direct current stimulation
tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are two electrodes, which are small metal discs, where the current comes from.
Sponsors
Rosetrees Trust
King's College London
University College, London
University of Oxford
University of East London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of major depressive disorder based on DSM-5 criteria * minimum score of 16 on Hamilton Rating Scale for Depression (HAM-D)
Exclusion criteria
* history of treatment-resistant depression * comorbid psychiatric disorder * significant risk of suicide or self harm * any contraindications to tDCS, including implanted electronic medical devices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response | At 6 weeks following course of tDCS treatment | As measured by a Hamilton Depression Rating Scale score that is less than or equal to 50% of the baseline Hamilton Depression Rating Scale score. Higher scores indicate greater depressive symptoms. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| tDCS 6-week course of active tDCS treatment, consisting of 5 sessions per week for the first 3 weeks followed by 2 sessions per week for 3 weeks, for a total of 21 tDCS sessions. The duration of each session is 30 minutes.
transcranial direct current stimulation: tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are two electrodes, which are small metal discs, where the current comes from. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | tDCS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 40.85 years STANDARD_DEVIATION 14.16 |
| Hamilton Depression Rating Scale score | 19.12 units on a scale STANDARD_DEVIATION 2.12 |
| Race/Ethnicity, Customized Any other Black/African/Caribbean background | 3 Participants |
| Race/Ethnicity, Customized Any other mixed/ Multiple ethnic background | 1 Participants |
| Race/Ethnicity, Customized Any other White Background | 1 Participants |
| Race/Ethnicity, Customized Chinese | 1 Participants |
| Race/Ethnicity, Customized Pakistani | 1 Participants |
| Race/Ethnicity, Customized White and Asian | 1 Participants |
| Race/Ethnicity, Customized White and Black African | 2 Participants |
| Race/Ethnicity, Customized White British | 16 Participants |
| Region of Enrollment United Kingdom | 26 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 26 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Clinical Response
As measured by a Hamilton Depression Rating Scale score that is less than or equal to 50% of the baseline Hamilton Depression Rating Scale score. Higher scores indicate greater depressive symptoms.
Time frame: At 6 weeks following course of tDCS treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS | Clinical Response | 22 Participants |