Trial Outcomes & Findings for Transcranial Direct Current Stimulation Therapy for Bipolar Depression (NCT NCT05436613)
NCT ID: NCT05436613
Last Updated: 2025-08-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-08-14
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Transcranial Direct Current Stimulation Therapy for Bipolar Depression
Baseline characteristics by cohort
| Measure |
Device: Transcranial Direct Current Stimulation
n=44 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
47.27 years
STANDARD_DEVIATION 12.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
44 participants
n=5 Participants
|
|
Ammons Quick Test (measure of IQ)
|
100.66 units on a scale
STANDARD_DEVIATION 9.29 • n=5 Participants
|
|
MADRS: Montgomery-Åsberg Depression Rating Scale
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24.59 units on a scale
STANDARD_DEVIATION 2.64 • n=5 Participants
|
|
HDRS-17: Hamilton Depression Rating Scale
|
19.98 units on a scale
STANDARD_DEVIATION 2.62 • n=5 Participants
|
|
HAMA: Hamilton Anxiety Rating Scale
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16.55 units on a scale
STANDARD_DEVIATION 5.26 • n=5 Participants
|
|
YMRS: Young Mania Rating Scale
|
2.20 units on a scale
STANDARD_DEVIATION 1.49 • n=5 Participants
|
|
PHQ-9: Patient Health Questionnaire-9
|
16.80 units on a scale
STANDARD_DEVIATION 4.94 • n=5 Participants
|
|
SDS: Sheehan Disability Scale
|
20.77 units on a scale
STANDARD_DEVIATION 5.87 • n=5 Participants
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PRIMARY outcome
Timeframe: 6 weeksPopulation: Intention to Treat analysis including all participants who enrolled
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.
Outcome measures
| Measure |
Device: Transcranial Direct Current Stimulation
n=44 Participants
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.
|
|---|---|
|
Number of Participants With Clinical Response [ Time Frame: At 6 Weeks Following Course of tDCS Treatment ]
|
34 Participants
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SECONDARY outcome
Timeframe: 6 weeks (visit 21)The number of participants who have completed a minimum of 15 tDCS sessions
Outcome measures
| Measure |
Device: Transcranial Direct Current Stimulation
n=44 Participants
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.
|
|---|---|
|
Participant Retention at the End of the Treatment
|
41 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Device: Transcranial Direct Current Stimulation
n=41 Participants
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.
|
|---|---|
|
Participant Acceptability Questionnaire Scales
|
41 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Device: Transcranial Direct Current Stimulation
n=44 Participants
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.
|
|---|---|
|
MADRS Remission Rate
|
21 Participants
|
Adverse Events
Device: Transcranial Direct Current Stimulation
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Device: Transcranial Direct Current Stimulation
n=44 participants at risk
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.
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|---|---|
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Immune system disorders
Throat Infection
|
2.3%
1/44 • Number of events 1 • 6 weeks
Adverse events reported during the trial
|
Other adverse events
| Measure |
Device: Transcranial Direct Current Stimulation
n=44 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Headache
|
20.5%
9/44 • Number of events 22 • 6 weeks
Adverse events reported during the trial
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
11.4%
5/44 • Number of events 24 • 6 weeks
Adverse events reported during the trial
|
|
Skin and subcutaneous tissue disorders
Tingling
|
97.7%
43/44 • Number of events 716 • 6 weeks
Adverse events reported during the trial
|
|
Skin and subcutaneous tissue disorders
Itching
|
22.7%
10/44 • Number of events 252 • 6 weeks
Adverse events reported during the trial
|
|
Skin and subcutaneous tissue disorders
Burning sensation
|
77.3%
34/44 • Number of events 226 • 6 weeks
Adverse events reported during the trial
|
|
Skin and subcutaneous tissue disorders
Skin redness
|
77.3%
34/44 • Number of events 347 • 6 weeks
Adverse events reported during the trial
|
|
Nervous system disorders
Trouble concentrating
|
4.5%
2/44 • Number of events 6 • 6 weeks
Adverse events reported during the trial
|
|
Nervous system disorders
Sleepiness
|
20.5%
9/44 • Number of events 25 • 6 weeks
Adverse events reported during the trial
|
|
Nervous system disorders
Acute mood change
|
9.1%
4/44 • Number of events 7 • 6 weeks
Adverse events reported during the trial
|
|
Skin and subcutaneous tissue disorders
Sore feeling at electrode site
|
4.5%
2/44 • Number of events 2 • 6 weeks
Adverse events reported during the trial
|
|
Ear and labyrinth disorders
Dizziness
|
4.5%
2/44 • Number of events 2 • 6 weeks
Adverse events reported during the trial
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.5%
2/44 • Number of events 3 • 6 weeks
Adverse events reported during the trial
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place