Clinical trial NCT04425278: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Major Depressive Disorder
Event-Related Potentials
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in Hamilton Depression Scale
timeFrame: baseline;14 day post-treatment
measure: Change from baseline in Motivation and Pleasure Scale
timeFrame: baseline;14 day post-treatment
Secondary outcomes:
measure: The change from baseline in behavioral results of Monetary Incentive Delay task
timeFrame: baseline; 14 day post-treatment change from baseline after the treatment.
measure: The change from baseline in event-related brain potentials during the monetary incentive delay task
timeFrame: baseline; 14 day post-treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
affiliation: Anhui Medical University
name: Kai Wang, MD
role: STUDY_CHAIR
affiliation: Anhui Medical University
name: Fengqiong Yu, MD
role: STUDY_DIRECTOR
References: