Major Depressive DisorderNCT06518642
Transcranial Direct Current Stimulation (tDCS) in Young Individuals with Major Depressive Disorder: a Literature Review and Feasibility Study
A study testing Sooma tDCS portable device - active stimulation in people with Major Depressive Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Objectives: (1) To assess the therapeutic effects of tDCS on improving depressive symptoms in young individuals with Major Depressive Disorder (MDD), relative to sham stimulation ; and (2) to evaluate the tolerability, and feasibility of tDCS in young individuals with Major Depressive Disorder, to explore the… Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Sooma tDCS portable device - active stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Jul 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with major depressive disorder (MDD) according to the Structured Clinical Interview for DSM-5, Clinical Version (SCID-DSM-5, CV)
- Scored ≥ 14 (i.e., at least mild to moderate depression on the 17-item Hamilton Depression Rating Scale (HDRS) at screening and at baseline;
- Right handedness;
- Stable dosage of antidepressants or other treatments for depression in recent 4 weeks; and
- Can read and write Chinese.
Who cannot join
- History of significant head trauma, neurological disorders (e.g., epilepsy), seizures;
- First degree relative with epilepsy;
- Concomitant unstable medical conditions; major neurological conditions;
- Comorbid disorders listed in the DSM-V, e.g., schizophrenia, substance use disorder, mental retardation, etc.;
- Pregnancy, lactating women, or women planning pregnancy;
- Device or metal clips on or inside the skull, cardiac pacemaker;
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: (1) To assess the therapeutic effects of tDCS on improving depressive symptoms in young individuals with Major Depressive Disorder (MDD), relative to sham stimulation ; and (2) to evaluate the tolerability, and feasibility of tDCS in young individuals with Major Depressive Disorder, to explore the feasibility for a scale-up study.
Hypothesis: 1) we hypothesize the tDCS stimulation of the dorsolateral prefrontal cortex (dLPFC) will reduce symptoms of depression more than sham stimulation, demonstrated by significant difference in change of Hamilton Depression Rating Scale (HDRS) and 2) tDCS active stimulation of the dLPFC will be tolerable and feasible among patients with MDD, as demonstrated by minimal adverse effects measured in the Adverse Events Questionnaire, adherence (with reasons of drop out), their motivation and enjoyment to participate in the study .
Read the detailed description
The incidence of probable depression during the fifth peak of COVID-19 was 24.6%, within the HK population, with the youths having experienced a disproportionately higher rate. A recent epidemiology survey conducted in HK revealed the 12-month prevalence of suicidal ideation among young individuals above secondary school age to be an alarming 8.4%. While guidelines and RCTs support the use of medication and psychotherapy as a standalone or combination treatments for major depressive disorder (MDD) in youths, a large proportion do not respond to either medication or psychotherapy. There is therefore an unmet need for new, effective treatment options for depression that can be tolerated by young individuals. Transcranial direct current simulation (tDCS) has its acute-effect is physiological change that reduces the threshold of membrane polarisation and increased the synaptic excitability. A handful of studies suggested that anodal stimulation of the dorsal lateral prefrontal cortex (DLPFC) is effective in reducing depressive symptoms in adults, however, whether similar effects applies to youth remains unknown. tDCS is portable, relatively inexpensive, and easy to use, proving to be very safe and tolerable for young individuals with minimal and temporary side effects.
- Conditions
- Major Depressive Disorder
- Being tested
- Sooma tDCS portable device - active stimulation, Sooma tDCS portable device - sham stimulation
- Keywords
- Major Depressive Disorder (MDD), Youth, Transcranial Direct Current Stimulation (tDCS), Augmentative treatment, Young adults, Adolescent
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sooma tDCS portable device - active stimulationDevice
Treatment followed common tDCS protocol upon considering safety and tolerability, comprising five consecutive sessions in five days of 30-minute 2 mA tDCS. We utilized the Soterix Medical tDCS device (Soterix Medical, New York, NY, USA, Model 1x1 tDCS-CT) in the research lab and the Sooma Oy device (Sooma Depression Therapy Comfort, Helsinki, Finland) for patient self-administration.Sooma provided two of their portable tDCS devices for a brief period, including one customized sham device.Due to the limited availability of the Sooma devices, participants were randomly allocated to either the Sooma or. Due to the limited availability of the Sooma devices, participants were randomly allocated to either the Sooma or the Soterix device based on availability during their initial session. A current of 2 mA was applied with the anode positioned left DLPFC, corresponding to area F3 in the international 10-20 system. The cathode (reference electrode) was applied at the right dPLFC, F4.
Sooma tDCS portable device - sham stimulationDevice
Sooma provided two of their portable tDCS devices for a brief period, including one customized sham device for effective blinding, distinguishable only by serial number and managed by an external data manager following the randomization sequence.To ensure blinding to the participant and their caregiver, at the beginning of the stimulation sessions, participants receiving both the active and sham stimulation would experience a ramp-up in current from 0 to 2 mA, and then the current would ramp down to 0 mA for participants receiving sham stimulation. Participants were told that they may experience sensations such as tingling, headache, or mild burning during the first 30-60 seconds of the stimulation session but that they may subside afterwards as they got used to it. In other words, participants would not be able to tell if diminishing of side effects were due to habituation (active tDCS) or ramping down of current (sham tDCS).
| Study group | Role | What they receive |
|---|---|---|
| active stimulation | Experimental | A current strength of two mA will be consistently applied for 30 minutes, with 30 seconds of ramping up and ramping down periods. Receives: Device: Sooma tDCS portable device - active stimulation |
| sham stimulation | Sham comparator | Current application will remain identical to the active stimulation, except that stimulation will be tampered off after 30 seconds. This duration (30 secs) was selected based on previous studies indicating that mild discomfort during active current application, such as tingling, would commonly be experienced up to 30 seconds only before subsiding Receives: Device: Sooma tDCS portable device - sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS) - 17 items
Measuring depressive symptoms, score ranges from 0 (minimum) to 53 (maximum); higher score indicates more severe depressive symptoms.
Measured: T0 (baseline); T1 (immedately after intervention)
Secondary outcomes (10)
Social and Occupational Functioning Assessment scale (SOFAS)
Measures social and occupational functioning across work functioning, independent functioning, immediate and extended social network functioning; score ranges from 0 (minimum) to 100 (maximum), higher score indicates higher social and occupational functioning ability.
Measured: T0 (baseline); T1 (immedately after intervention)
Role Functioning Scale (RFS)
Measures role functioning in four areas: work productivity, independent living, immediate and extended social network relationships; score ranges from 0 (minimum) to 7 (maximum) on each aspect, higher score indicates better role functioning
Measured: T0 (baseline); T1 (immedately after intervention)
Global Functioning: Social Scale and Role Scale
Measures social and role functioning; score ranges from 1 (minimum) to 10 (maximum); higher score indicates better social/role functioning
Measured: T0 (baseline); T1 (immedately after intervention)
Short Form Health Survey (SF-12)
Short-form measure of health status with 12 questions.
Measured: T0 (baseline); T1 (immedately after intervention)
Clinical Global Impression Scale
Measures the severity of illness and global improvement following an intervention; scores ranges from 1 (normal/very much improved) to 7 (most severely ill/very much worse), with higher scores indicating worse outcome.
Measured: T1 (immedately after intervention)
Beck Scale of Suicidal Ideation.
Measures self-reported suicidal ideation; score ranges from 0 (minimum) to 38 (maximum), with higher scores indicating a greater risk of suicide.
Measured: T0 (baseline); T1 (immedately after intervention)
Visual Analog Scale (VAS)
Two VASs were used to measure motivation and willingness during intervention. Each VAS contains a scale of 0 (minimum) to 10 (maximum) with higher scores indicating more
Measured: T0 (baseline); T1 (immedately after intervention)
Chinese version of the Snaith-Hamilton Pleasure Scale (C-SHAPS)
Gold standard, self-rated scale measuring anhedonia symptoms. Each item ranges from 0 to 3, hence total score ranges from 0 (minimum) to 42 (maximum) with higher scores indicating more anhedonic symptoms
Measured: T0 (baseline); T1 (immedately after intervention)
Chinese version of the Dimensional Anhedonia Rating Scale (C-DARS)
17-item self-rated questionnaire measuring anhedonia symptoms. Each item ranges from 0 to 4, hence total score ranges from 0 (minimum) to 68 (maximum) with higher scores indicating lower levels of anhedonia symptoms
Measured: T0 (baseline); T1 (immedately after intervention)
Adherence rate to the participation of the tDCS study
Adherence rate of full participation in each tDCS session; and the reason of skipping the tDCS session if any
Measured: from T0 (baseline) to T1 (immedately after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start31 Jul 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518642
- Sponsor's protocol ID
- tDCS_depression
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) in Young Individuals with Major Depressive Disorder: a Literature Review and Feasibility Study
- ClinicalTrials.gov ID
- NCT06518642
- Acronym / sponsor ID
- tDCS_depression
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder (MDD), Youth, Transcranial Direct Current Stimulation (tDCS), Augmentative treatment, Young adults, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: (1) To assess the therapeutic effects of tDCS on improving depressive symptoms in young individuals with Major Depressive Disorder (MDD), relative to sham stimulation ; and (2) to evaluate the tolerability, and feasibility of tDCS in young individuals with Major Depressive Disorder, to explore the feasibility for a scale-up study.
Hypothesis: 1) we hypothesize the tDCS stimulation of the dorsolateral prefrontal cortex (dLPFC) will reduce symptoms of depression more than sham stimulation, demonstrated by significant difference in change of Hamilton Depression Rating Scale (HDRS) and 2) tDCS active stimulation of the dLPFC will be tolerable and feasible among patients with MDD, as demonstrated by minimal adverse effects measured in the Adverse Events Questionnaire, adherence (with reasons of drop out), their motivation and enjoyment to participate in the study .
Detailed description
The incidence of probable depression during the fifth peak of COVID-19 was 24.6%, within the HK population, with the youths having experienced a disproportionately higher rate. A recent epidemiology survey conducted in HK revealed the 12-month prevalence of suicidal ideation among young individuals above secondary school age to be an alarming 8.4%. While guidelines and RCTs support the use of medication and psychotherapy as a standalone or combination treatments for major depressive disorder (MDD) in youths, a large proportion do not respond to either medication or psychotherapy. There is therefore an unmet need for new, effective treatment options for depression that can be tolerated by young individuals. Transcranial direct current simulation (tDCS) has its acute-effect is physiological change that reduces the threshold of membrane polarisation and increased the synaptic excitability. A handful of studies suggested that anodal stimulation of the dorsal lateral prefrontal cortex (DLPFC) is effective in reducing depressive symptoms in adults, however, whether similar effects applies to youth remains unknown. tDCS is portable, relatively inexpensive, and easy to use, proving to be very safe and tolerable for young individuals with minimal and temporary side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active stimulation | Experimental | Device: Sooma tDCS portable device - active stimulationA current strength of two mA will be consistently applied for 30 minutes, with 30 seconds of ramping up and ramping down periods. |
| sham stimulation | Sham comparator | Device: Sooma tDCS portable device - sham stimulationCurrent application will remain identical to the active stimulation, except that stimulation will be tampered off after 30 seconds. This duration (30 secs) was selected based on previous studies indicating that mild discomfort during active current application, such as tingling, would commonly be experienced up to 30 seconds only before subsiding |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with major depressive disorder (MDD) according to the Structured Clinical Interview for DSM-5, Clinical Version (SCID-DSM-5, CV)
- Scored ≥ 14 (i.e., at least mild to moderate depression on the 17-item Hamilton Depression Rating Scale (HDRS) at screening and at baseline;
- Right handedness;
- Stable dosage of antidepressants or other treatments for depression in recent 4 weeks; and
- Can read and write Chinese.
Key exclusion criteria (7 listed)
- History of significant head trauma, neurological disorders (e.g., epilepsy), seizures;
- First degree relative with epilepsy;
- Concomitant unstable medical conditions; major neurological conditions;
- Comorbid disorders listed in the DSM-V, e.g., schizophrenia, substance use disorder, mental retardation, etc.;
- Pregnancy, lactating women, or women planning pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sooma tDCS portable device - active stimulationTreatment followed common tDCS protocol upon considering safety and tolerability, comprising five consecutive sessions in five days of 30-minute 2 mA tDCS. We utilized the Soterix Medical tDCS device (Soterix Medical, New York, NY, USA, Model 1x1 tDCS-CT) in the research lab and the Sooma Oy device (Sooma Depression Therapy Comfort, Helsinki, Finland) for patient self-administration.Sooma provided two of their portable tDCS devices for a brief period, including one customized sham device.Due to the limited availability of the Sooma devices, participants were randomly allocated to either the Sooma or. Due to the limited availability of the Sooma devices, participants were randomly allocated to either the Sooma or the Soterix device based on availability during their initial session. A current of 2 mA was applied with the anode positioned left DLPFC, corresponding to area F3 in the international 10-20 system. The cathode (reference electrode) was applied at the right dPLFC, F4. | Device | active stimulation |
| Sooma tDCS portable device - sham stimulationSooma provided two of their portable tDCS devices for a brief period, including one customized sham device for effective blinding, distinguishable only by serial number and managed by an external data manager following the randomization sequence.To ensure blinding to the participant and their caregiver, at the beginning of the stimulation sessions, participants receiving both the active and sham stimulation would experience a ramp-up in current from 0 to 2 mA, and then the current would ramp down to 0 mA for participants receiving sham stimulation. Participants were told that they may experience sensations such as tingling, headache, or mild burning during the first 30-60 seconds of the stimulation session but that they may subside afterwards as they got used to it. In other words, participants would not be able to tell if diminishing of side effects were due to habituation (active tDCS) or ramping down of current (sham tDCS). | Device | sham stimulation |
Primary outcome
Hamilton Depression Rating Scale (HDRS) - 17 items
Time frame: T0 (baseline); T1 (immedately after intervention)
Measuring depressive symptoms, score ranges from 0 (minimum) to 53 (maximum); higher score indicates more severe depressive symptoms.
10 secondary outcomes
Social and Occupational Functioning Assessment scale (SOFAS)
Time frame: T0 (baseline); T1 (immedately after intervention)
Role Functioning Scale (RFS)
Time frame: T0 (baseline); T1 (immedately after intervention)
Global Functioning: Social Scale and Role Scale
Time frame: T0 (baseline); T1 (immedately after intervention)
Short Form Health Survey (SF-12)
Time frame: T0 (baseline); T1 (immedately after intervention)
Clinical Global Impression Scale
Time frame: T1 (immedately after intervention)
Beck Scale of Suicidal Ideation.
Time frame: T0 (baseline); T1 (immedately after intervention)
Visual Analog Scale (VAS)
Time frame: T0 (baseline); T1 (immedately after intervention)
Chinese version of the Snaith-Hamilton Pleasure Scale (C-SHAPS)
Time frame: T0 (baseline); T1 (immedately after intervention)
Chinese version of the Dimensional Anhedonia Rating Scale (C-DARS)
Time frame: T0 (baseline); T1 (immedately after intervention)
Adherence rate to the participation of the tDCS study
Time frame: from T0 (baseline) to T1 (immedately after intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sooma tDCS portable device - active stimulation in people with Major Depressive Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HDRS) - 17 items (time frame: T0 (baseline); T1 (immedately after intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.