Effects of transcranial direct current electrical stimulation on major depressive disorder

JRCT ID: jRCTs052220086

Registered date:12/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Major depressive disorder
• Date of first enrollment: 21/06/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Electrodes are placed over the dorsolateral prefrontal cortex (DLPFC) using DC stimulator MR (neuroCOnn Gmbh). In a total of 20 daily sessions that lasted 20 minutes per day, 2 mA of direct current stimulation is administered in each session.

Outcome(s)

Primary Outcome

1) The primary efficacy outcomes are the changes from baseline in symptom rationg scale, including Hamilton Depression Rating Scale (HAMD-17), the Mental and Physical Ques tionnaire (PHQ), and the Beck Depression Questionnaire, Second Edition (BDI-II)
2) Safety is evaluated by evaluated by Proposal of a questionnaire surveying for tDCS adverse effects (PQSTAE)

Key inclusion & exclusion criteria

• Age minimum: >= 25age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

The inclusion criteria are as follows:
1) Inpatients in the department of psychiatry of the University of Fukui Hospital
2) Male or female patients between 25 and 90 years of age
3) Diagnosed major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5; American Psychiatric Association)
4) Moderate to severe depressive state according to the Hamilton Depression Rating Scale (score <= 17)
5) Patients provides written informed consent prior to initiation of any study procedures

Exclude criteria

Exclusion criteria
1) Past or current diagnosis of schizophrenia, schizoaffective disorder, bipolar I disorder and bipolar II disorder
2) Presence of severe physical diseases or in the terminal phase of the disease
3) Under treatment for thyroid function abnormality
4) With abnormal EEG findings
5) With intracranial space-occupying lesion
6) pregnancy
7) Need to be cured urgently due to severe depressive state with inability take any food and/or severe suicidal ideation
8) Lack of cooperation regarding 20-minutes procedure of tDCS due to severe agitation

Related Information

• Primary Sponsor: Omori M Ichiro