Transcranial Direct Current StimulationNCT04425278
tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder
A study testing transcranial direct current stimulation with real current in people with Transcranial Direct Current Stimulation and Major Depressive Disorder, run by Anhui Medical University at 1 site in China.
Trial summary
Study of tDCS intervention on motivational anhedonia of Major Depressive Disorder Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Transcranial Direct Current Stimulation, Major Depressive Disorder, Event-Related Potentials
- What is being tested?
- transcranial direct current stimulation with real current
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 31 Dec 2021
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet criteria of depression assessed by at least two psychiatrists according to the five version of Diagnostic and Statistical Manual of Mental Disorders.
- The score of Hamilton Depression Rating Scale-17 was larger than 18.
- Patients were taking antidepressants--Selective Serotonin Reuptake Inhibitor(SSRIs) alone.
- Age was between 18 to 60 year old.
- The education duration was at least 6 years.
- The vision or corrected vision was normal.
- Right handedness.
- No treatment of rTMS, transcranial direct current stimulation or electroconvulsive therapy before.
Who cannot join
- History of significant head trauma or neurological disorders.
- Alcohol or drug abuse.
- Focal brain lesions.
- History of seizure.
- First degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease.
- Significant unstable medical condition.
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- Recent aggression or other forms of behavioral dyscontrol.
- Left-handedness.
- Pregnancy.
- Current alcohol or drug abuse
- Inability to provide informed consent.
- Patients with contraindications or factors affecting imaging quality, such as pacemakers, cochlear implants, or hearts Cerebrovascular metal stent, and metal denture.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Medical University
Hefei, Anhui, 230032
Fengqiong Yu, yufengqin1@163.com
About this study
Official title: Study of tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder
Study of tDCS intervention on motivational anhedonia of Major Depressive Disorder
Read the detailed description
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after transcranial direct current stimulation (tDCS) treatment. Patients were randomly allocated to real group , sham group or control group. A threshold of 3 points on the Hamilton Depression scale has been specified by the National Institute for Health and Care Excellence to determine a clinically meaningful difference between active pharmacotherapy and placebo. We plan to enroll minimum total sample size of 37 participants in real, sham or control group respectively according to the Power and Sample Size program. The decision to enroll a patient was always made prior to randomization. The tDCS administrators had access to the randomization list. They had minimal contact with the patients, and no role in assessing depression. Each patient would be treated for continuous 14 days by tDCS in real and sham group. The control group was evaluated by clinical symptom scale, behavioral evaluation before and after 14 days.
Before the tDCS treatment, depression symptom of each participant was assessed by the Hamilton Depression Scale and the Beck Depression Self-Rating Scale. The anhedonia severity was evaluated by The Temporal Experience of Pleasure Scale, the Self-Report Apathy Evaluation Scale, Dimensional Anhedonia Rating Scale, the Motivation and Pleasure Scale.The neuroimaging data was collected using event-related potentials during monetary incentive delay task. After the last treatment, the same scales and neuroimaging scan were used again to assess the treatment effect of the tDCS and the underlying brain mechanism. Each participant was interviewed in detail about the adverse event of the tDCS intervention during the past 14 days.Every participant should take part in the study in voluntary and sign an informed consent form before the study.
- Conditions
- Transcranial Direct Current Stimulation, Major Depressive Disorder, Event-Related Potentials
- Being tested
- transcranial direct current stimulation with real current, transcranial direct current stimulation with sham current
- 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.
transcranial direct current stimulation with real currentDevice
transcranial direct current stimulation with real current is a noninvasive technique to activate and modify the activity of the neurons
transcranial direct current stimulation with sham currentDevice
transcranial direct current stimulation with sham current is a placebo
| Study group | Role | What they receive |
|---|---|---|
| Real Stimulation | Active comparator | The Real Stimulation of tDCS lasted 20 mins.Behavior and ERPs dataset should be acquired before the first tDCS session and after the last tDCS session. Receives: Device: transcranial direct current stimulation with real current |
| Sham Stimulation | Sham comparator | The Sham Stimulation of tDCS lasted 20 minutes with no current. In particular, the current went up for the first 30 seconds and went down for the last 30 seconds.Behavior and ERPs dataset should be acquired before the first tDCS session and after the last tDCS session. Receives: Device: transcranial direct current stimulation with sham current |
| Control | No intervention | Behavior and ERPs dataset should be acquired before and after 14 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hamilton Depression Scale
The participants' depression symptom assessed by the Hamilton Depression Scale change from baseline after the treatment.
Measured: baseline;14 day post-treatment
Change from baseline in Motivation and Pleasure Scale
The severity of participants' anhedonia assessed by the Motivation and Pleasure Scale change from baseline after the treatment.
Measured: baseline;14 day post-treatment
Secondary outcomes (2)
The change from baseline in behavioral results of Monetary Incentive Delay task
The motivational anhedonia assessed by accuracy and response time in Monetary Incentive Delay task
Measured: baseline; 14 day post-treatment change from baseline after the treatment.
The change from baseline in event-related brain potentials during the monetary incentive delay task
The amplitudes of brain potentials of contingent negative variation and P3 assessed by event-related brain potentials methods change from baseline after the treatment.
Measured: baseline; 14 day post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Mar 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengqiong Yu, Anhui Medical University
- Investigators
- Kai Wang, MD, Study chair, Anhui Medical UniversityFengqiong Yu, MD, Study director, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425278
- Sponsor's protocol ID
- Yu
- Status last verified
- Jun 2020
- First submitted
- 29 May 2020
- Last updated
- 11 Jun 2020
- 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 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04425278
- Acronym / sponsor ID
- Yu
- Conditions
- Transcranial Direct Current Stimulation, Major Depressive Disorder, Event-Related Potentials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Jun 2020 (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.
Study of tDCS intervention on motivational anhedonia of Major Depressive Disorder
Detailed description
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after transcranial direct current stimulation (tDCS) treatment. Patients were randomly allocated to real group , sham group or control group. A threshold of 3 points on the Hamilton Depression scale has been specified by the National Institute for Health and Care Excellence to determine a clinically meaningful difference between active pharmacotherapy and placebo. We plan to enroll minimum total sample size of 37 participants in real, sham or control group respectively according to the Power and Sample Size program. The decision to enroll a patient was always made prior to randomization. The tDCS administrators had access to the randomization list. They had minimal contact with the patients, and no role in assessing depression. Each patient would be treated for continuous 14 days by tDCS in real and sham group. The control group was evaluated by clinical symptom scale, behavioral evaluation before and after 14 days.
Before the tDCS treatment, depression symptom of each participant was assessed by the Hamilton Depression Scale and the Beck Depression Self-Rating Scale. The anhedonia severity was evaluated by The Temporal Experience of Pleasure Scale, the Self-Report Apathy Evaluation Scale, Dimensional Anhedonia Rating Scale, the Motivation and Pleasure Scale.The neuroimaging data was collected using event-related potentials during monetary incentive delay task. After the last treatment, the same scales and neuroimaging scan were used again to assess the treatment effect of the tDCS and the underlying brain mechanism. Each participant was interviewed in detail about the adverse event of the tDCS intervention during the past 14 days.Every participant should take part in the study in voluntary and sign an informed consent form before the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real Stimulation | Active comparator | Device: transcranial direct current stimulation with real currentThe Real Stimulation of tDCS lasted 20 mins.Behavior and ERPs dataset should be acquired before the first tDCS session and after the last tDCS session. |
| Sham Stimulation | Sham comparator | Device: transcranial direct current stimulation with sham currentThe Sham Stimulation of tDCS lasted 20 minutes with no current. In particular, the current went up for the first 30 seconds and went down for the last 30 seconds.Behavior and ERPs dataset should be acquired before the first tDCS session and after the last tDCS session. |
| Control | No intervention | –Behavior and ERPs dataset should be acquired before and after 14 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Meet criteria of depression assessed by at least two psychiatrists according to the five version of Diagnostic and Statistical Manual of Mental Disorders.
- The score of Hamilton Depression Rating Scale-17 was larger than 18.
- Patients were taking antidepressants--Selective Serotonin Reuptake Inhibitor(SSRIs) alone.
- Age was between 18 to 60 year old.
- The education duration was at least 6 years.
Key exclusion criteria (12 listed)
- History of significant head trauma or neurological disorders.
- Alcohol or drug abuse.
- Focal brain lesions.
- History of seizure.
- First degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease.
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 |
|---|---|---|
| transcranial direct current stimulation with real currenttranscranial direct current stimulation with real current is a noninvasive technique to activate and modify the activity of the neurons | Device | Real Stimulation |
| transcranial direct current stimulation with sham currenttranscranial direct current stimulation with sham current is a placebo | Device | Sham Stimulation |
Primary outcome
Change from baseline in Hamilton Depression Scale
Time frame: baseline;14 day post-treatment
The participants' depression symptom assessed by the Hamilton Depression Scale change from baseline after the treatment.
Change from baseline in Motivation and Pleasure Scale
Time frame: baseline;14 day post-treatment
The severity of participants' anhedonia assessed by the Motivation and Pleasure Scale change from baseline after the treatment.
2 secondary outcomes
The change from baseline in behavioral results of Monetary Incentive Delay task
Time frame: baseline; 14 day post-treatment change from baseline after the treatment.
The change from baseline in event-related brain potentials during the monetary incentive delay task
Time frame: baseline; 14 day post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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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.
Kai Wang, MD study chair
Anhui Medical University
Fengqiong Yu, MD study director
Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation with real current in people with Transcranial Direct Current Stimulation and Major Depressive Disorder, run by Anhui Medical University at 1 site in China.
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 12 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 11 Jun 2020. 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 China. 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 Fengqiong Yu, MD (0086055115955155423, yufengqin1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Hamilton Depression Scale (time frame: baseline;14 day post-treatment). The study lists 2 primary outcomes in all. 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 11 Jun 2020.