tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder

  • STATUS
    Recruiting
  • participants needed
    90
  • sponsor
    Anhui Medical University
Updated on 16 February 2024
antidepressants
depressive disorder
psychiatric disorder
electroconvulsive therapy
transcranial magnetic stimulation
selective serotonin reuptake inhibitors
anhedonia
depression
transcranial direct current stimulation
psychiatric disorders
major depressive disorder
serotonin reuptake inhibitors
ssris

Summary

Study of tDCS intervention on motivational anhedonia of Major Depressive Disorder

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.

Details
Condition Major depression, Endogenous depression, Evoked Potentials, Transcranial Direct Current Stimulation
Age 18years - 60years
Treatment transcranial direct current stimulation with real current, transcranial direct current stimulation with sham current
Clinical Study IdentifierNCT04425278
SponsorAnhui Medical University
Last Modified on16 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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