tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder
Primary Purpose
Transcranial Direct Current Stimulation, Major Depressive Disorder, Event-Related Potentials
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcranial direct current stimulation with real current
transcranial direct current stimulation with sham current
Sponsored by
About this trial
This is an interventional treatment trial for Transcranial Direct Current Stimulation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Anhui Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
No Intervention
Arm Label
Real Stimulation
Sham Stimulation
Control
Arm Description
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.
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.
Behavior and ERPs dataset should be acquired before and after 14 days.
Outcomes
Primary Outcome Measures
Change from baseline in Hamilton Depression Scale
The participants' depression symptom assessed by the Hamilton Depression Scale change from baseline after the 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.
Secondary Outcome Measures
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04425278
Brief Title
tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder
Official Title
Study of tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anhui Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Direct Current Stimulation, Major Depressive Disorder, Event-Related Potentials
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Real Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Behavior and ERPs dataset should be acquired before and after 14 days.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation with real current
Intervention Description
transcranial direct current stimulation with real current is a noninvasive technique to activate and modify the activity of the neurons
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation with sham current
Intervention Description
transcranial direct current stimulation with sham current is a placebo
Primary Outcome Measure Information:
Title
Change from baseline in Hamilton Depression Scale
Description
The participants' depression symptom assessed by the Hamilton Depression Scale change from baseline after the treatment.
Time Frame
baseline;14 day post-treatment
Title
Change from baseline in Motivation and Pleasure Scale
Description
The severity of participants' anhedonia assessed by the Motivation and Pleasure Scale change from baseline after the treatment.
Time Frame
baseline;14 day post-treatment
Secondary Outcome Measure Information:
Title
The change from baseline in behavioral results of Monetary Incentive Delay task
Description
The motivational anhedonia assessed by accuracy and response time in Monetary Incentive Delay task
Time Frame
baseline; 14 day post-treatment change from baseline after the treatment.
Title
The change from baseline in event-related brain potentials during the monetary incentive delay task
Description
The amplitudes of brain potentials of contingent negative variation and P3 assessed by event-related brain potentials methods change from baseline after the treatment.
Time Frame
baseline; 14 day post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fengqiong Yu, MD
Phone
0086055115955155423
Email
yufengqin1@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Wang, MD
Organizational Affiliation
Anhui Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fengqiong Yu, MD
Organizational Affiliation
Anhui Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengqiong Yu
Email
yufengqin1@163.com
12. IPD Sharing Statement
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tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder
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