tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder

NCT04425278 | Unknown DMC

• 1 other identifier: Yu
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Study of tDCS intervention on motivational anhedonia of Major Depressive Disorder

Conditions

Transcranial Direct Current Stimulation; Major Depressive Disorder; Event-Related Potentials

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The change from baseline in behavioral results of 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

  baseline; 14 day post-treatment

Study Arms (3)

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.

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.

Device: transcranial direct current stimulation with sham current

Control

NO INTERVENTION

Behavior and ERPs dataset should be acquired before and after 14 days.

Interventions

transcranial direct current stimulation with real current DEVICE

transcranial direct current stimulation with real current is a noninvasive technique to activate and modify the activity of the neurons

Real Stimulation

transcranial direct current stimulation with sham current DEVICE

transcranial direct current stimulation with sham current is a placebo

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Kai Wang, MD

  Anhui Medical University

  STUDY CHAIR

• Fengqiong Yu, MD

  Anhui Medical University

  STUDY DIRECTOR

Central Study Contacts

Fengqiong Yu, MD

CONTACT

0086055115955155423; yufengqin1@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A/Prof.

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 11, 2020
• Study Start: March 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

CN (1)