Bipolar Disorder, Depression, Bipolar, Mental Disorder, Mood Disorders
Conditions
Brief summary
Bipolar disorder is a severe and disabling disorder. The course of illness is often progressive but is highly heterogeneous between individuals and within the lifetime for an individual. The most common treatments are medications. However, for many individuals, combinations of medications are often required, and full recovery is infrequent. The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar depression. The present research question is whether tDCS can be provided as a home-based treatment for bipolar depression for adults with bipolar disorder.
Detailed description
The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar disorder. tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a headband worn over the forehead with 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 present study is a proof-of-concept trial to assess the efficacy, acceptability and safety of tDCS treatment for bipolar depression within a community-based setting.
Interventions
DEVICETranscranial Direct Current Stimulation
tDCS at 2mA in 30 minute sessions for 5 sessions per week for 3 weeks and then 2 sessions per week for 3 weeks.
Sponsors
University College, London
King's College London
Technische Universität Dresden
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 bipolar disorder based on DSM-5 criteria * minimum score of 18 on the MADRS * being on a stable dosage of mood stabilizing medication for a minimum of two weeks
Exclusion criteria
* comorbid psychiatric disorder * significant risk of suicide or self harm * any contraindications to tDCS, including implanted electronic medical devices * history of epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Response [ Time Frame: At 6 Weeks Following Course of tDCS Treatment ] | 6 weeks | As measured by clinician-rated Montgomery Asberg Depression Rating Scale (MADRS) score improvement of 50% or more from baseline following the course of tDCS treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Retention at the End of the Treatment | 6 weeks (visit 21) | The number of participants who have completed a minimum of 15 tDCS sessions |
| Participant Acceptability Questionnaire Scales | Week 6 (Visit 21) | Participants were asked how acceptable they found the tDCS treatment after the 6-week course of treatment. They were given responses on a 7-point Likert style scale. The number of participants who rated the tDCS treatment as acceptable on the Treatment Acceptability Questionnaire (Likert responses 5, 6 or 7) are reported. |
Other
| Measure | Time frame | Description |
|---|---|---|
| MADRS Remission Rate | 6 weeks (Visit 21) | Trained rater measure of depressive symptoms: Montgomery-Åsberg Depression Rating Scale (MADRS) remission rate: a score of less than 10 following the course of tDCS |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device: Transcranial Direct Current Stimulation 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 at 2mA in 30 minute sessions for 5 sessions per week for 3 weeks and then 2 sessions per week for 3 weeks. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Device: Transcranial Direct Current Stimulation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Age, Continuous | 47.27 years STANDARD_DEVIATION 12.89 |
| Ammons Quick Test (measure of IQ) | 100.66 units on a scale STANDARD_DEVIATION 9.29 |
| HAMA: Hamilton Anxiety Rating Scale | 16.55 units on a scale STANDARD_DEVIATION 5.26 |
| HDRS-17: Hamilton Depression Rating Scale | 19.98 units on a scale STANDARD_DEVIATION 2.62 |
| MADRS: Montgomery-Åsberg Depression Rating Scale | 24.59 units on a scale STANDARD_DEVIATION 2.64 |
| PHQ-9: Patient Health Questionnaire-9 | 16.80 units on a scale STANDARD_DEVIATION 4.94 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United Kingdom | 44 participants |
| SDS: Sheehan Disability Scale | 20.77 units on a scale STANDARD_DEVIATION 5.87 |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 13 Participants |
| YMRS: Young Mania Rating Scale | 2.20 units on a scale STANDARD_DEVIATION 1.49 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44 |
| other Total, other adverse events | 43 / 44 |
| serious Total, serious adverse events | 1 / 44 |
Outcome results
Primary
Number of Participants With Clinical Response [ Time Frame: At 6 Weeks Following Course of tDCS Treatment ]
As measured by clinician-rated Montgomery Asberg Depression Rating Scale (MADRS) score improvement of 50% or more from baseline following the course of tDCS treatment.
Time frame: 6 weeks
Population: Intention to Treat analysis including all participants who enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Transcranial Direct Current Stimulation | Number of Participants With Clinical Response [ Time Frame: At 6 Weeks Following Course of tDCS Treatment ] | 34 Participants |
Secondary
Participant Acceptability Questionnaire Scales
Participants were asked how acceptable they found the tDCS treatment after the 6-week course of treatment. They were given responses on a 7-point Likert style scale. The number of participants who rated the tDCS treatment as acceptable on the Treatment Acceptability Questionnaire (Likert responses 5, 6 or 7) are reported.
Time frame: Week 6 (Visit 21)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Transcranial Direct Current Stimulation | Participant Acceptability Questionnaire Scales | 41 Participants |
Secondary
Participant Retention at the End of the Treatment
The number of participants who have completed a minimum of 15 tDCS sessions
Time frame: 6 weeks (visit 21)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Transcranial Direct Current Stimulation | Participant Retention at the End of the Treatment | 41 Participants |
Other Pre-specified
MADRS Remission Rate
Trained rater measure of depressive symptoms: Montgomery-Åsberg Depression Rating Scale (MADRS) remission rate: a score of less than 10 following the course of tDCS
Time frame: 6 weeks (Visit 21)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Transcranial Direct Current Stimulation | MADRS Remission Rate | 21 Participants |