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临床试验/NCT04425278
NCT04425278Unknown不适用

Study of tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder

Anhui Medical University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
Change from baseline in Hamilton Depression Scale

研究概览

简要总结

Study of tDCS intervention on motivational anhedonia of Major Depressive Disorder

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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
  • •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.

排除标准

  • •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.
  • •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.

研究组 & 干预措施

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.

干预措施: transcranial direct current stimulation with real current (Device)

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.

干预措施: transcranial direct current stimulation with sham current (Device)

Control

No Intervention

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

结局指标

主要结局

Change from baseline in Hamilton Depression Scale

时间窗: baseline;14 day post-treatment

The participants' depression symptom assessed by the Hamilton Depression Scale change from baseline after the treatment.

Change from baseline in Motivation and Pleasure Scale

时间窗: baseline;14 day post-treatment

The severity of participants' anhedonia assessed by the Motivation and Pleasure Scale change from baseline after the treatment.

次要结局

  • The change from baseline in event-related brain potentials during the monetary incentive delay task(baseline; 14 day post-treatment)
  • The change from baseline in behavioral results of Monetary Incentive Delay task(baseline; 14 day post-treatment change from baseline after the treatment.)

研究者

发起方
Anhui Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fengqiong Yu

A/Prof.

Anhui Medical University

研究点 (1)

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