Depression in Old AgeNCT05322863
High-definition Transcranial Direct Current Stimulation (HD-tDCS) in Late-life Depression (LLD)
A study testing High-definition Transcranial Direct Current Stimulation in people with Depression in Old Age, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
To determine the efficacy of a 2-week daily programme (10 sessions) of HD-tDCS to augment antidepressant therapy in subjects with late-life depression who had residual depressive symptoms despite adequate dosage and duration of antidepressant therapy. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression in Old Age
- What is being tested?
- High-definition Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Feb 2021to 22 Feb 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years of age or above
- Right-handedness, as determined by the Edinburgh Handedness Inventory (to homogenise neuroanatomical targeting)
- Chinese ethnicity
- Fulfil the criteria of Major Depressive Disorder (single or recurrent episode) and in partial remission, defined by the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Presence of mild to severe level of depressive symptoms measured and defined by HAM-D-17 score ≥8 and ≤ 52[22]
- Suboptimal treatment response with at least one adequate antidepressant trial defined as full or best tolerated doses at least 6 weeks
- Stable dosage of antidepressants or other treatments for depression in recent 4 weeks
- Valid informed written consent
Who cannot join
- A DSM-5 diagnosis other than Depressive Disorders (e.g., bipolar and related disorders, schizophrenia spectrum and other psychotic disorders).
- A Hong Kong Chinese version of the Montreal Cognitive Assessment (HK-MoCA) score below the second percentile according to the subject's age and education level (to exclude subjects with existing dementia)
- Alcohol or substance dependence
- Active suicidal ideation or a suicide attempt within the past month
- Concomitant unstable medical condition or major neurological conditions
- Significant communication impairment
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Psychiatry, University of Hong Kong
Hong Kong
Pak Wing Calvin Cheng, 22554486, chengpsy@hku.hk
About this study
Official title: High-definition Transcranial Direct Current Stimulation (HD-tDCS) as Augmentation Therapy in Late-life Depression (LLD) With Suboptimal Response to Treatment - Double-blinded Randomized Sham-controlled Trial
To determine the efficacy of a 2-week daily programme (10 sessions) of HD-tDCS to augment antidepressant therapy in subjects with late-life depression who had residual depressive symptoms despite adequate dosage and duration of antidepressant therapy.
Read the detailed description
Background:
Hong Kong is facing a significant challenge in ageing population. A significant proportion of older adults suffered from depression. As the local population is ageing rapidly, the burden of late-life depression (LLD) will continue to increase. LLD is associated with a poorer long term prognosis, a more chronic course and a higher relapse rate comparing with adult-onset depression. Treatment response towards medication is unsatisfactory. Over 50% of patients with LLD do not achieve symptomatic remission. With the growing ageing population in Hong Kong, LLD becomes a pressing problem. The mainstream treatment of LLD is antidepressant and electroconvulsive therapy (ECT). Despite these methods being shown to be effective, there are limitations in each of these treatments. A new treatment option or augmentation therapy would be needed to improve the treatment response in LLD. Transcranial direct current stimulation (tDCS) is a non-invasive neurostimulation method. It applies a weak, direct electric current over the scalp region. It is a very safe intervention tool. It exerts the treatment effect probably through the change in the activity of neurons and modulation in synaptic release probability uptake and sensitivity. It enhances the long-term plasticity (LTP) and changes the rate of neurotransmitter release. High-definition tDCS (HD-tDCS) allows for more accuracy and focus on targeting the specific brain region. Recent evidence suggested that tDCS and serotonin enhance each other's function. Controversial outcomes were reported in previous randomised controlled trials (RCT) focusing on adult patients with depression. There is no RCT done among patients with LLD. An open-label pilot study was conducted by our team in 2018 which showed a significant improvement in depressive symptoms and mild improvement in cognitive domains after 2 weeks of HD-tDCS intervention.
Objectives:
This study is a double-blinded randomized sham-controlled trial to test the effectiveness of HD-tDCS as augmentation therapy for antidepressants in patients with LLD. The investigators hypothesized that active HD-tDCS is significantly more effective than sham control in reducing depressive symptoms.
Design:
The current study is a 2-week intervention trial of HD-tDCS with 4-week and 12-week post-intervention observation. All eligible participants must receive at least four weeks of antidepressant treatment before the tDCS intervention. Then they will be randomised to receive either active HD-tDCS (a-HD-tDCS) or sham-HD-tDCS (s-HD-tDCS) intervention for two weeks with five sessions per week. Both the participants and the investigators responsible for assessments and data analysis will be blinded to the group allocation. Total ten sessions HD-tDCS will be delivered. Each session would last for 30 minutes. After HD-tDCS intervention, participants would continue their medications for at least for 12 more weeks until all post-intervention assessments are complete.
Data Analysis:
Primary outcome and secondary outcomes assessment would be carried out at baseline, immediately after the intervention and follow
- up assessments at 4 and 12 weeks. The primary outcome will be the change of Hamilton depression rating scale (HAM-D-17). Secondary outcomes will include cognitive assessments, anxiety symptoms, daily functioning and adverse effects of the intervention. Intention-to
- treat analysis would be carried out. Intention-to-treat analysis would be carried out.
Significance:
The result of the current study would provide further data on the effectiveness of HD-tDCS as augmentative therapy with antidepressants in LLD patients.
- Conditions
- Depression in Old Age
- Being tested
- High-definition Transcranial Direct Current Stimulation
- Keywords
- augmentation therapy, late-life depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-definition Transcranial Direct Current StimulationDevice
The HD-tDCS will be administered by the program device called Starstim (Neuroelectrics). All participants will receive the treatment by using the same model of device. The HD-tDCS device can be portable and controlled wirelessly via computer software developed by the manufacturer. The montages will be a '4 × 1 ring set-up', which is the most commonly used HD-tDCS setting. The centre anode electrode is surrounded by four return cathode electrodes. The anode will be placed over the left dorsal lateral prefrontal cortex. Conductive electrode gel will be applied on the scalp at all designated electrode stimulation areas. A cap appropriate for each participants' head size will be used to ensure that the electrodes are secured in place. Impedance checks will be performed using the Starstim software before each treatment session.
| Study group | Role | What they receive |
|---|---|---|
| active HD-tDCS | Active comparator | The participants will be instructed to relax during the first 5 minutes of the session while the equipment is set up. A mild stimulation (with a level of only 2 milliamps stimulation) will be delivered for 20 minutes, with the current gradually increased and decreased over 30 seconds. The patients will be instructed to relax and remain motionless during the intervention. The administrator will closely monitor the impedance throughout each session and record any side effects experienced by the participants. The participants will be allowed 5 minutes of rest after the intervention and will be actively asked about any discomfort. Each session will last around 30 minutes, with a total of 10 sessions (two consecutive weeks of treatment for 5 days per week). Receives: Device: High-definition Transcranial Direct Current Stimulation |
| sham-HD-tDCS | Sham comparator | The procedure for sham stimulation will be identical, except that the current will be gradually ramped down to zero after the first 30 s, thus giving the same initial sensation of HD-tDCS. The stimulator will be programmed to switch the current on and off, so no intervention by the operator will be required. The computer will be placed behind the subjects' heads so they cannot see the readout. Receives: Device: High-definition Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Depressive symptoms
the clinical response rate and the remission rate as measured with the HAM-D-17. A clinical response will be defined as a reduction of 50% or more in the HAM-D-17 score. A HAM-D-17 score of 7 or less will be used as an indicator of remission. Scores range from 0 to 52, with higher scores indicating more severe depression.
Measured: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Secondary outcomes (8)
Change in the Global Cognition
Using the Hong Kong Chinese version of the Montreal Cognitive Assessment. The total score ranges from 0-30 with higher scores indicating better cognition.
Measured: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in the Working Memory
Measured by forward and backward digit span.
Measured: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in the Executive Functioning
Measured by the Trail Making Test Parts A and B.
Measured: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in the Verbal Fluency
Measured by category verbal fluency test.
Measured: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in the Attention
Measured by the Stroop test.
Measured: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in the Anxiety symptoms
Measured by the Hamilton Anxiety Rating Scale (HAMA). It is a widely used clinician-rated scale ranging from 0-56, with higher marks represent more severe in anxiety symptoms.
Measured: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in Daily functioning
Instrumental activities of daily living will be assessed with the Hong Kong Chinese version of the Lawton Instrumental Activities of Daily Living Scale. The daily functioning would be assessed with a total score ranging from 0 to 27. A higher score indicates a higher functioning level.
Measured: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in Adverse effects and risk indicators
checklist of potential adverse effects associated with t-DCS administration will be generated from the available literature. Risk indicators such as suicidal risk or severe self-neglect that would necessitate immediate changes to treatment will be directly assessed according to the risk and needs.
Measured: Assessed immediately after each (in total 10) individual treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start22 Feb 2021
- Primary completion22 Feb 2023 (estimated)
- Study completion22 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Depression in Old AgeStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cheng Pak Wing, Calvin, The University of Hong Kong
- Investigators
- Pak Wing Calvin Cheng, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322863
- Sponsor's protocol ID
- 20191119
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chi I, Yip PS, Chiu HF, Chou KL, Chan KS, Kwan CW, Conwell Y, Caine E. Prevalence of depression and its correlates in Hong Kong's Chinese older adults. Am J Geriatr Psychiatry. 2005 May;13(5):409-16. doi: 10.1176/appi.ajgp.13.5.409.
PubMed 15879590Mitchell AJ, Subramaniam H. Prognosis of depression in old age compared to middle age: a systematic review of comparative studies. Am J Psychiatry. 2005 Sep;162(9):1588-601. doi: 10.1176/appi.ajp.162.9.1588.
PubMed 16135616Schatzberg A, Roose S. A double-blind, placebo-controlled study of venlafaxine and fluoxetine in geriatric outpatients with major depression. Am J Geriatr Psychiatry. 2006 Apr;14(4):361-70. doi: 10.1097/01.JGP.0000194645.70869.3b.
PubMed 16582045Blazer DG. Depression in late life: review and commentary. J Gerontol A Biol Sci Med Sci. 2003 Mar;58(3):249-65. doi: 10.1093/gerona/58.3.m249.
PubMed 12634292World Health Organization. Depression. Fact sheet No. 369/October 2012
Schulz R, Drayer RA, Rollman BL. Depression as a risk factor for non-suicide mortality in the elderly. Biol Psychiatry. 2002 Aug 1;52(3):205-25. doi: 10.1016/s0006-3223(02)01423-3.
PubMed 12182927Baldwin RC. Refractory depression in late life: a review of treatment options. Rev Clin Gerontol. 1996;6(4):343-8.
Alam M, Truong DQ, Khadka N, Bikson M. Spatial and polarity precision of concentric high-definition transcranial direct current stimulation (HD-tDCS). Phys Med Biol. 2016 Jun 21;61(12):4506-21. doi: 10.1088/0031-9155/61/12/4506. Epub 2016 May 25.
PubMed 27223853Kuo HI, Bikson M, Datta A, Minhas P, Paulus W, Kuo MF, Nitsche MA. Comparing cortical plasticity induced by conventional and high-definition 4 x 1 ring tDCS: a neurophysiological study. Brain Stimul. 2013 Jul;6(4):644-8. doi: 10.1016/j.brs.2012.09.010. Epub 2012 Oct 13.
PubMed 23149292Zimmerman M, Martinez JH, Young D, Chelminski I, Dalrymple K. Severity classification on the Hamilton Depression Rating Scale. J Affect Disord. 2013 Sep 5;150(2):384-8. doi: 10.1016/j.jad.2013.04.028. Epub 2013 Jun 4.
PubMed 23759278Kalu UG, Sexton CE, Loo CK, Ebmeier KP. Transcranial direct current stimulation in the treatment of major depression: a meta-analysis. Psychol Med. 2012 Sep;42(9):1791-800. doi: 10.1017/S0033291711003059. Epub 2012 Jan 12.
PubMed 22236735Zheng YP, Zhao JP, Phillips M, Liu JB, Cai MF, Sun SQ, Huang MF. Validity and reliability of the Chinese Hamilton Depression Rating Scale. Br J Psychiatry. 1988 May;152:660-4. doi: 10.1192/bjp.152.5.660.
PubMed 3167442Nikolin S, Huggins C, Martin D, Alonzo A, Loo CK. Safety of repeated sessions of transcranial direct current stimulation: A systematic review. Brain Stimul. 2018 Mar-Apr;11(2):278-288. doi: 10.1016/j.brs.2017.10.020. Epub 2017 Oct 31.
PubMed 29169814Das S, Holland P, Frens MA, Donchin O. Impact of Transcranial Direct Current Stimulation (tDCS) on Neuronal Functions. Front Neurosci. 2016 Nov 30;10:550. doi: 10.3389/fnins.2016.00550. eCollection 2016.
PubMed 27965533Fritsch B, Reis J, Martinowich K, Schambra HM, Ji Y, Cohen LG, Lu B. Direct current stimulation promotes BDNF-dependent synaptic plasticity: potential implications for motor learning. Neuron. 2010 Apr 29;66(2):198-204. doi: 10.1016/j.neuron.2010.03.035.
PubMed 20434997
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-definition Transcranial Direct Current Stimulation (HD-tDCS) as Augmentation Therapy in Late-life Depression (LLD) With Suboptimal Response to Treatment - Double-blinded Randomized Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT05322863
- Acronym / sponsor ID
- 20191119
- Conditions
- Depression in Old Age
- Keywords
- augmentation therapy, late-life depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 22 Feb 2023 (estimated)
- Study completion
- 22 Feb 2024 (estimated)
- First posted
- 12 Apr 2022 (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.
To determine the efficacy of a 2-week daily programme (10 sessions) of HD-tDCS to augment antidepressant therapy in subjects with late-life depression who had residual depressive symptoms despite adequate dosage and duration of antidepressant therapy.
Detailed description
Background:
Hong Kong is facing a significant challenge in ageing population. A significant proportion of older adults suffered from depression. As the local population is ageing rapidly, the burden of late-life depression (LLD) will continue to increase. LLD is associated with a poorer long term prognosis, a more chronic course and a higher relapse rate comparing with adult-onset depression. Treatment response towards medication is unsatisfactory. Over 50% of patients with LLD do not achieve symptomatic remission. With the growing ageing population in Hong Kong, LLD becomes a pressing problem. The mainstream treatment of LLD is antidepressant and electroconvulsive therapy (ECT). Despite these methods being shown to be effective, there are limitations in each of these treatments. A new treatment option or augmentation therapy would be needed to improve the treatment response in LLD. Transcranial direct current stimulation (tDCS) is a non-invasive neurostimulation method. It applies a weak, direct electric current over the scalp region. It is a very safe intervention tool. It exerts the treatment effect probably through the change in the activity of neurons and modulation in synaptic release probability uptake and sensitivity. It enhances the long-term plasticity (LTP) and changes the rate of neurotransmitter release. High-definition tDCS (HD-tDCS) allows for more accuracy and focus on targeting the specific brain region. Recent evidence suggested that tDCS and serotonin enhance each other's function. Controversial outcomes were reported in previous randomised controlled trials (RCT) focusing on adult patients with depression. There is no RCT done among patients with LLD. An open-label pilot study was conducted by our team in 2018 which showed a significant improvement in depressive symptoms and mild improvement in cognitive domains after 2 weeks of HD-tDCS intervention.
Objectives:
This study is a double-blinded randomized sham-controlled trial to test the effectiveness of HD-tDCS as augmentation therapy for antidepressants in patients with LLD. The investigators hypothesized that active HD-tDCS is significantly more effective than sham control in reducing depressive symptoms.
Design:
The current study is a 2-week intervention trial of HD-tDCS with 4-week and 12-week post-intervention observation. All eligible participants must receive at least four weeks of antidepressant treatment before the tDCS intervention. Then they will be randomised to receive either active HD-tDCS (a-HD-tDCS) or sham-HD-tDCS (s-HD-tDCS) intervention for two weeks with five sessions per week. Both the participants and the investigators responsible for assessments and data analysis will be blinded to the group allocation. Total ten sessions HD-tDCS will be delivered. Each session would last for 30 minutes. After HD-tDCS intervention, participants would continue their medications for at least for 12 more weeks until all post-intervention assessments are complete.
Data Analysis:
Primary outcome and secondary outcomes assessment would be carried out at baseline, immediately after the intervention and follow
- up assessments at 4 and 12 weeks. The primary outcome will be the change of Hamilton depression rating scale (HAM-D-17). Secondary outcomes will include cognitive assessments, anxiety symptoms, daily functioning and adverse effects of the intervention. Intention-to
- treat analysis would be carried out. Intention-to-treat analysis would be carried out.
Significance:
The result of the current study would provide further data on the effectiveness of HD-tDCS as augmentative therapy with antidepressants in LLD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active HD-tDCS | Active comparator | Device: High-definition Transcranial Direct Current StimulationThe participants will be instructed to relax during the first 5 minutes of the session while the equipment is set up. A mild stimulation (with a level of only 2 milliamps stimulation) will be delivered for 20 minutes, with the current gradually increased and decreased over 30 seconds. The patients will be instructed to relax and remain motionless during the intervention. The administrator will closely monitor the impedance throughout each session and record any side effects experienced by the participants. The participants will be allowed 5 minutes of rest after the intervention and will be actively asked about any discomfort. Each session will last around 30 minutes, with a total of 10 sessions (two consecutive weeks of treatment for 5 days per week). |
| sham-HD-tDCS | Sham comparator | Device: High-definition Transcranial Direct Current StimulationThe procedure for sham stimulation will be identical, except that the current will be gradually ramped down to zero after the first 30 s, thus giving the same initial sensation of HD-tDCS. The stimulator will be programmed to switch the current on and off, so no intervention by the operator will be required. The computer will be placed behind the subjects' heads so they cannot see the readout. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 60 years of age or above
- Right-handedness, as determined by the Edinburgh Handedness Inventory (to homogenise neuroanatomical targeting)
- Chinese ethnicity
- Fulfil the criteria of Major Depressive Disorder (single or recurrent episode) and in partial remission, defined by the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Presence of mild to severe level of depressive symptoms measured and defined by HAM-D-17 score ≥8 and ≤ 52[22]
Key exclusion criteria (6 listed)
- A DSM-5 diagnosis other than Depressive Disorders (e.g., bipolar and related disorders, schizophrenia spectrum and other psychotic disorders).
- A Hong Kong Chinese version of the Montreal Cognitive Assessment (HK-MoCA) score below the second percentile according to the subject's age and education level (to exclude subjects with existing dementia)
- Alcohol or substance dependence
- Active suicidal ideation or a suicide attempt within the past month
- Concomitant unstable medical condition or major neurological conditions
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 |
|---|---|---|
| High-definition Transcranial Direct Current StimulationThe HD-tDCS will be administered by the program device called Starstim (Neuroelectrics). All participants will receive the treatment by using the same model of device. The HD-tDCS device can be portable and controlled wirelessly via computer software developed by the manufacturer. The montages will be a '4 × 1 ring set-up', which is the most commonly used HD-tDCS setting. The centre anode electrode is surrounded by four return cathode electrodes. The anode will be placed over the left dorsal lateral prefrontal cortex. Conductive electrode gel will be applied on the scalp at all designated electrode stimulation areas. A cap appropriate for each participants' head size will be used to ensure that the electrodes are secured in place. Impedance checks will be performed using the Starstim software before each treatment session. | Device | active HD-tDCS, sham-HD-tDCS |
Primary outcome
Change in the Depressive symptoms
Time frame: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
the clinical response rate and the remission rate as measured with the HAM-D-17. A clinical response will be defined as a reduction of 50% or more in the HAM-D-17 score. A HAM-D-17 score of 7 or less will be used as an indicator of remission. Scores range from 0 to 52, with higher scores indicating more severe depression.
8 secondary outcomes
Change in the Global Cognition
Time frame: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in the Working Memory
Time frame: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in the Executive Functioning
Time frame: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in the Verbal Fluency
Time frame: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in the Attention
Time frame: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in the Anxiety symptoms
Time frame: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in Daily functioning
Time frame: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Change in Adverse effects and risk indicators
Time frame: Assessed immediately after each (in total 10) individual treatment session.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Background: PubMed 15879590Chi I, Yip PS, Chiu HF, Chou KL, Chan KS, Kwan CW, Conwell Y, Caine E. Prevalence of depression and its correlates in Hong Kong's Chinese older adults. Am J Geriatr Psychiatry. 2005 May;13(5):409-16. doi: 10.1176/appi.ajgp.13.5.409.
- Background: PubMed 16135616Mitchell AJ, Subramaniam H. Prognosis of depression in old age compared to middle age: a systematic review of comparative studies. Am J Psychiatry. 2005 Sep;162(9):1588-601. doi: 10.1176/appi.ajp.162.9.1588.
- Background: PubMed 16582045Schatzberg A, Roose S. A double-blind, placebo-controlled study of venlafaxine and fluoxetine in geriatric outpatients with major depression. Am J Geriatr Psychiatry. 2006 Apr;14(4):361-70. doi: 10.1097/01.JGP.0000194645.70869.3b.
- Background: PubMed 12634292Blazer DG. Depression in late life: review and commentary. J Gerontol A Biol Sci Med Sci. 2003 Mar;58(3):249-65. doi: 10.1093/gerona/58.3.m249.
- BackgroundWorld Health Organization. Depression. Fact sheet No. 369/October 2012
- Background: PubMed 12182927Schulz R, Drayer RA, Rollman BL. Depression as a risk factor for non-suicide mortality in the elderly. Biol Psychiatry. 2002 Aug 1;52(3):205-25. doi: 10.1016/s0006-3223(02)01423-3.
- BackgroundBaldwin RC. Refractory depression in late life: a review of treatment options. Rev Clin Gerontol. 1996;6(4):343-8.
- Background: PubMed 27223853Alam M, Truong DQ, Khadka N, Bikson M. Spatial and polarity precision of concentric high-definition transcranial direct current stimulation (HD-tDCS). Phys Med Biol. 2016 Jun 21;61(12):4506-21. doi: 10.1088/0031-9155/61/12/4506. Epub 2016 May 25.
- Background: PubMed 23149292Kuo HI, Bikson M, Datta A, Minhas P, Paulus W, Kuo MF, Nitsche MA. Comparing cortical plasticity induced by conventional and high-definition 4 x 1 ring tDCS: a neurophysiological study. Brain Stimul. 2013 Jul;6(4):644-8. doi: 10.1016/j.brs.2012.09.010. Epub 2012 Oct 13.
- Background: PubMed 23759278Zimmerman M, Martinez JH, Young D, Chelminski I, Dalrymple K. Severity classification on the Hamilton Depression Rating Scale. J Affect Disord. 2013 Sep 5;150(2):384-8. doi: 10.1016/j.jad.2013.04.028. Epub 2013 Jun 4.
- Background: PubMed 22236735Kalu UG, Sexton CE, Loo CK, Ebmeier KP. Transcranial direct current stimulation in the treatment of major depression: a meta-analysis. Psychol Med. 2012 Sep;42(9):1791-800. doi: 10.1017/S0033291711003059. Epub 2012 Jan 12.
- Background: PubMed 3167442Zheng YP, Zhao JP, Phillips M, Liu JB, Cai MF, Sun SQ, Huang MF. Validity and reliability of the Chinese Hamilton Depression Rating Scale. Br J Psychiatry. 1988 May;152:660-4. doi: 10.1192/bjp.152.5.660.
- Individual participant dataSharing planned: No
Related trials for Depression in Old Age
Not yet recruiting
Cognitive Enhancement in Recurrent Depression (The COG-D-R Study)
Aging, Depression
Recruiting
Effectiveness of Health Communication on Depression Elderly in Ho Chi Minh City
Depression - Major Depressive Disorder
RecruitingPhase 3
A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
Depressive Disorder, Major
Active, not recruiting
Neurophysiological RCT of Qigong in Elderly With Depression
Depression
RecruitingPhase 3
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Depressive Disorder, Major
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.
Pak Wing Calvin Cheng principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-definition Transcranial Direct Current Stimulation in people with Depression in Old Age, 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pak Wing Calvin Cheng (22554486, chengpsy@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Depressive symptoms (time frame: Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05322863, which also lists 25 linked publications.
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 12 Apr 2022.