Trial Outcomes & Findings for Home-based tDCS in Major Depressive Disorder (NCT NCT04799405)
NCT ID: NCT04799405
Last Updated: 2022-03-24
Results Overview
The MADRS is a 10-item clinical rating scale to measure the severity of depressive symptoms based on a clinical interview with a participant/patient. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60, and includes questions related to: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Cut off points are: 0 to 6 - normal, symptom absent, 7 to 19 - mild depression, 20 to 34 - moderate depression, \>34 - severe depression. Clinical remission is considered as a MADRS score ≤ 10. The primary outcome will be total MADRS score from baseline to one-month follow-up (pre and post-intervention; 12 weeks).
COMPLETED
NA
5 participants
12 weeks
2022-03-24
Participant Flow
No significant events occurred between participant enrollment and start of the intervention.
Participant milestones
| Measure |
tDCS MDD
A group of participants with major depressive disorder (MDD).
tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.
tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.
Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
1. First taper phase: three 30 minutes tDCS sessions applied every other day;
2. Second taper phase: three 30 minutes tDCS sessions applied one every third day;
3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.
|
|---|---|
|
Phase 1 - Acute Stimulation, Daily tDCS
STARTED
|
5
|
|
Phase 1 - Acute Stimulation, Daily tDCS
COMPLETED
|
3
|
|
Phase 1 - Acute Stimulation, Daily tDCS
NOT COMPLETED
|
2
|
|
Phase 2 - Tapered Stimulation Schedule
STARTED
|
3
|
|
Phase 2 - Tapered Stimulation Schedule
COMPLETED
|
3
|
|
Phase 2 - Tapered Stimulation Schedule
NOT COMPLETED
|
0
|
|
Phase 3 - Follow up Phase
STARTED
|
3
|
|
Phase 3 - Follow up Phase
COMPLETED
|
3
|
|
Phase 3 - Follow up Phase
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
tDCS MDD
A group of participants with major depressive disorder (MDD).
tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.
tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.
Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
1. First taper phase: three 30 minutes tDCS sessions applied every other day;
2. Second taper phase: three 30 minutes tDCS sessions applied one every third day;
3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.
|
|---|---|
|
Phase 1 - Acute Stimulation, Daily tDCS
Withdrawal by Subject
|
2
|
Baseline Characteristics
Home-based tDCS in Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
tDCS MDD
n=5 Participants
A group of 5 participants with major depressive disorder (MDD).
tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.
tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.
Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
1. First taper phase: three 30 minutes tDCS sessions applied every other day;
2. Second taper phase: three 30 minutes tDCS sessions applied one every third day;
3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.
|
|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
35 units on a scale
n=5 Participants
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
|
33.2 units on a scale
n=5 Participants
|
|
Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16)
|
17.6 units on a scale
n=5 Participants
|
|
Beck Depression Inventory (BDI)
|
24.8 units on a scale
n=5 Participants
|
|
Hamilton Depression Rating Scale (HDRS)
|
19.8 units on a scale
n=5 Participants
|
|
Montreal Cognitive Assessment (MoCA)
|
27.8 units on a scale
n=5 Participants
|
|
Digit Span Forward
|
7.6 Count of numbers correctly recalled
n=5 Participants
|
|
Digit Span Backward
|
6 Count of numbers correctly recalled
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: A group of participants with major depressive disorder (MDD).
The MADRS is a 10-item clinical rating scale to measure the severity of depressive symptoms based on a clinical interview with a participant/patient. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60, and includes questions related to: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Cut off points are: 0 to 6 - normal, symptom absent, 7 to 19 - mild depression, 20 to 34 - moderate depression, \>34 - severe depression. Clinical remission is considered as a MADRS score ≤ 10. The primary outcome will be total MADRS score from baseline to one-month follow-up (pre and post-intervention; 12 weeks).
Outcome measures
| Measure |
tDCS MDD
n=3 Participants
A group of participants with major depressive disorder (MDD).
tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.
tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.
Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
1. First taper phase: three 30 minutes tDCS sessions applied every other day;
2. Second taper phase: three 30 minutes tDCS sessions applied one every third day;
3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.
|
|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
16 units on a scale
Interval 6.0 to 25.0
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: A group of participants with major depressive disorder (MDD).
Feasibility and tolerability/safety will be evaluated using home-based data as recorded in the Neuroelectrics portal: number of missed sessions and number of adverse events reported on adverse event questionnaire
Outcome measures
| Measure |
tDCS MDD
n=3 Participants
A group of participants with major depressive disorder (MDD).
tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.
tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.
Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
1. First taper phase: three 30 minutes tDCS sessions applied every other day;
2. Second taper phase: three 30 minutes tDCS sessions applied one every third day;
3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.
|
|---|---|
|
Number of Treatment-Emergent Adverse Events [Safety and Tolerability] and Missed Sessions
Number of missed sessions
|
1 number of sessions/events
|
|
Number of Treatment-Emergent Adverse Events [Safety and Tolerability] and Missed Sessions
Number of treatment-emergent adverse events
|
0 number of sessions/events
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: A group of participants with Major Depressive Disorder (MDD).
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item questionnaire that captures life satisfaction over the past week across several domains. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). The Total Score is reported as percentage maximum possible % Max = Raw-minimum score/maximum score-minimum score. (Raw score minus the minimum possible raw score divided by the maximum possible raw score minus the minimum possible raw score). This measure was administered at baseline and at 1 month follow-up, which were separated by 12 weeks.
Outcome measures
| Measure |
tDCS MDD
n=3 Participants
A group of participants with major depressive disorder (MDD).
tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.
tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.
Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
1. First taper phase: three 30 minutes tDCS sessions applied every other day;
2. Second taper phase: three 30 minutes tDCS sessions applied one every third day;
3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.
|
|---|---|
|
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
|
44.6667 units on a scale
Interval 42.0 to 48.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: A group of participants with major depressive disorder (MDD).
The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16) is a self-report measure of depressed symptomology. Questions in the QIDS - SR-16 correlate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia) (Q 1 - 4), Sad mood (Q 5), Decrease/increase in appetite/weight (Q 6 - 9), Concentration (Q 10), Self-criticism (Q 11), Suicidal ideation (Q 12), Interest (Q 13), Energy/fatigue (Q 14), Psychomotor agitation/retardation (Q 15 - 16). Severity of depression can be judged based on the total score, which ranges from 0 to 27. 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression This measure was administered at baseline and at 1 month follow-up, which were separated by 12 weeks.
Outcome measures
| Measure |
tDCS MDD
n=3 Participants
A group of participants with major depressive disorder (MDD).
tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.
tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.
Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
1. First taper phase: three 30 minutes tDCS sessions applied every other day;
2. Second taper phase: three 30 minutes tDCS sessions applied one every third day;
3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.
|
|---|---|
|
The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16)
|
5.3333 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: A group of participants with major depressive disorder (MDD).
The Beck Depression Inventory (BDI) is 21-item multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. For each item, a value of 0 to 3 is assigned and then the total score is summed. The standard cut-offs are as follows: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms. This scale was given at baseline and 12 weeks later at the 1-month follow-up visit.
Outcome measures
| Measure |
tDCS MDD
n=3 Participants
A group of participants with major depressive disorder (MDD).
tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.
tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.
Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
1. First taper phase: three 30 minutes tDCS sessions applied every other day;
2. Second taper phase: three 30 minutes tDCS sessions applied one every third day;
3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.
|
|---|---|
|
Beck Depression Inventory (BDI)
|
10.3333 units on a scale
Interval 2.0 to 18.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: A group of participants with major depressive disorder (MDD).
Hamilton Depression Rating Scale (HDRS) is comprised of 21 items for inquiry, and only the first 17 are used in scoring. Each question examines a different symptom or aspect of depression, including: mood, guilt, suicidal ideation, insomnia, agitation, and somatic symptoms. Items are scaled either from 0 - 2 or 0 - 4, and each item is summed for a total score. Benchmarks suggested at: 0-7 normal; 8 - 13 mild depression; 14-18 moderate depression; 19-22 severe depression ; \>=23 very severe depression. This scale was administered at baseline and 12 weeks later at the 1-month follow-up visit.
Outcome measures
| Measure |
tDCS MDD
n=3 Participants
A group of participants with major depressive disorder (MDD).
tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.
tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.
Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
1. First taper phase: three 30 minutes tDCS sessions applied every other day;
2. Second taper phase: three 30 minutes tDCS sessions applied one every third day;
3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.
|
|---|---|
|
Hamilton Depression Rating Scale
|
7.3333 units on a scale
Interval 1.0 to 14.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: A group of participants with major depressive disorder (MDD).
The Montreal Cognitive Assessment (MoCA) is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains. The total possible score is 30 points; a score of 26 or above is considered normal. Severity of impairment can be determined with the following scores: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment. The maximum total score is 30 and the minimum total score is 0 points. This assessment was administered at baseline and at 1 month post-intervention (12 week span).
Outcome measures
| Measure |
tDCS MDD
n=3 Participants
A group of participants with major depressive disorder (MDD).
tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.
tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.
Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
1. First taper phase: three 30 minutes tDCS sessions applied every other day;
2. Second taper phase: three 30 minutes tDCS sessions applied one every third day;
3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.
|
|---|---|
|
Montreal Cognitive Assessment (MoCA)
|
28.6667 units on a scale
Interval 28.0 to 30.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: A group of participants with major depressive disorder (MDD).
A digit-span forward task measures working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to recall the sequence of numbers verbally in the order that it was presented to the participant. The number of digits on the first trial is three. The length of the sequence increases with each correct trial completion. The more numbers recalled the better a participants has done.
Outcome measures
| Measure |
tDCS MDD
n=3 Participants
A group of participants with major depressive disorder (MDD).
tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.
tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.
Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
1. First taper phase: three 30 minutes tDCS sessions applied every other day;
2. Second taper phase: three 30 minutes tDCS sessions applied one every third day;
3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.
|
|---|---|
|
Digit Span Forward
|
8 Count of numbers correctly recalled
Interval 7.0 to 9.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: A group of participants with major depressive disorder (MDD).
A digit-span task backwards measures working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to recall the sequence of numbers verbally in backwards order. The number of digits on the first trial is two. The length of the sequence increases with each correct trial completion. The more numbers recalled the better a participants has done.
Outcome measures
| Measure |
tDCS MDD
n=3 Participants
A group of participants with major depressive disorder (MDD).
tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.
tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.
Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
1. First taper phase: three 30 minutes tDCS sessions applied every other day;
2. Second taper phase: three 30 minutes tDCS sessions applied one every third day;
3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.
|
|---|---|
|
Digit Span Backward
|
6 Count of numbers correctly recalled
Interval 4.0 to 8.0
|
Adverse Events
tDCS MDD
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place