tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder

Study of tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder

Study of tDCS intervention on motivational anhedonia of Major Depressive Disorder

Study Overview

• Status: Unknown
• Conditions: Major Depressive Disorder; Transcranial Direct Current Stimulation; Event-Related Potentials
• Intervention / Treatment: Device: transcranial direct current stimulation with real current; Device: transcranial direct current stimulation with sham current

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230032
      • Recruiting
      • Anhui Medical University
      • Contact: Fengqiong Yu; Email: yufengqin1@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Meet criteria of depression assessed by at least two psychiatrists according to the five version of Diagnostic and Statistical Manual of Mental Disorders.
2. The score of Hamilton Depression Rating Scale-17 was larger than 18.
3. Patients were taking antidepressants--Selective Serotonin Reuptake Inhibitor(SSRIs) alone.
4. Age was between 18 to 60 year old.
5. The education duration was at least 6 years.
6. The vision or corrected vision was normal.
7. Right handedness.
8. No treatment of rTMS, transcranial direct current stimulation or electroconvulsive therapy before.

Exclusion Criteria:

1. History of significant head trauma or neurological disorders.
2. Alcohol or drug abuse.
3. Focal brain lesions.
4. History of seizure.
5. First degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease.
6. Significant unstable medical condition.
7. Recent aggression or other forms of behavioral dyscontrol.
8. Left-handedness.
9. Pregnancy.
10. Current alcohol or drug abuse
11. Inability to provide informed consent.
12. Patients with contraindications or factors affecting imaging quality, such as pacemakers, cochlear implants, or hearts Cerebrovascular metal stent, and metal denture.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Real Stimulation; 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.	Device: transcranial direct current stimulation with real current; transcranial direct current stimulation with real current is a noninvasive technique to activate and modify the activity of the neurons
Sham Comparator: Sham Stimulation; 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.	Device: transcranial direct current stimulation with sham current; transcranial direct current stimulation with sham current is a placebo
No Intervention: Control; Behavior and ERPs dataset should be acquired before and after 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Hamilton Depression Scale	The participants' depression symptom assessed by the Hamilton Depression Scale change from baseline after the treatment.	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.	baseline;14 day post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	baseline; 14 day post-treatment

Collaborators and Investigators

• Sponsor: Anhui Medical University
• Investigators: Study Chair: Kai Wang, MD, Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Mood Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Depression; Depressive Disorder; Anhedonia; Depressive Disorder, Major
• Other Study ID Numbers: Yu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No