tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder

NCT ID: NCT04425278

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2021-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation with real current

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

transcranial direct current stimulation with sham current

Intervention Type: DEVICE

transcranial direct current stimulation with sham current is a placebo

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

transcranial direct current stimulation with sham current

transcranial direct current stimulation with sham current is a placebo

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Fengqiong Yu

A/Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kai Wang, MD

Role: STUDY_CHAIR

Anhui Medical University

Fengqiong Yu, MD

Role: STUDY_DIRECTOR

Anhui Medical University

Locations

Anhui Medical University

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fengqiong Yu, MD

Role: CONTACT

yufengqin1@163.com

0086055115955155423

Facility Contacts

Fengqiong Yu

Role: primary

yufengqin1@163.com

Other Identifiers

Yu

Identifier Type: -

Identifier Source: org_study_id