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High-definition Transcranial Direct Current Stimulation (HD-tDCS) in Late-life Depression (LLD)

Primary Purpose

Depression in Old Age

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
High-definition Transcranial Direct Current Stimulation
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression in Old Age focused on measuring augmentation therapy, late-life depression

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 60 years of age or above
  2. Right-handedness, as determined by the Edinburgh Handedness Inventory (to homogenise neuroanatomical targeting)
  3. Chinese ethnicity
  4. 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)
  5. Presence of mild to severe level of depressive symptoms measured and defined by HAM-D-17 score ≥8 and ≤ 52[22]
  6. Suboptimal treatment response with at least one adequate antidepressant trial defined as full or best tolerated doses at least 6 weeks
  7. Stable dosage of antidepressants or other treatments for depression in recent 4 weeks
  8. Valid informed written consent

Exclusion Criteria:

  1. A DSM-5 diagnosis other than Depressive Disorders (e.g., bipolar and related disorders, schizophrenia spectrum and other psychotic disorders).
  2. 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)
  3. Alcohol or substance dependence
  4. Active suicidal ideation or a suicide attempt within the past month
  5. Concomitant unstable medical condition or major neurological conditions
  6. Significant communication impairment

Sites / Locations

  • Department of Psychiatry, University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active HD-tDCS

sham-HD-tDCS

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in the Working Memory
Measured by forward and backward digit span.
Change in the Executive Functioning
Measured by the Trail Making Test Parts A and B.
Change in the Verbal Fluency
Measured by category verbal fluency test.
Change in the Attention
Measured by the Stroop test.
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.
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.
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.

Full Information

First Posted
March 24, 2022
Last Updated
April 11, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05322863
Brief Title
High-definition Transcranial Direct Current Stimulation (HD-tDCS) in Late-life Depression (LLD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
February 22, 2023 (Anticipated)
Study Completion Date
February 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Old Age
Keywords
augmentation therapy, late-life depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active HD-tDCS
Arm Type
Active Comparator
Arm Description
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).
Arm Title
sham-HD-tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High-definition Transcranial Direct Current Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Depressive symptoms
Description
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.
Time Frame
Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Secondary Outcome Measure Information:
Title
Change in the Global Cognition
Description
Using the Hong Kong Chinese version of the Montreal Cognitive Assessment. The total score ranges from 0-30 with higher scores indicating better cognition.
Time Frame
Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Title
Change in the Working Memory
Description
Measured by forward and backward digit span.
Time Frame
Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Title
Change in the Executive Functioning
Description
Measured by the Trail Making Test Parts A and B.
Time Frame
Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Title
Change in the Verbal Fluency
Description
Measured by category verbal fluency test.
Time Frame
Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Title
Change in the Attention
Description
Measured by the Stroop test.
Time Frame
Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Title
Change in the Anxiety symptoms
Description
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.
Time Frame
Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Title
Change in Daily functioning
Description
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.
Time Frame
Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.
Title
Change in Adverse effects and risk indicators
Description
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.
Time Frame
Assessed immediately after each (in total 10) individual treatment session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pak Wing Calvin Cheng
Phone
22554486
Email
chengpsy@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pak Wing Calvin Cheng
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pak Wing Calvin Cheng
Phone
22554486
Email
chengpsy@hku.hk

12. IPD Sharing Statement

Plan to Share IPD
No
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High-definition Transcranial Direct Current Stimulation (HD-tDCS) in Late-life Depression (LLD)

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