se of brain stimulation for treatment of Depressio

Not Applicable

Conditions: Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic features

Registration Number: CTRI/2023/03/050546

Lead Sponsor: All India Institute of Medical Sciences New Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Between age 18-55 years

2.Either gender

3.Right-handed individuals

4.Patients fulfilling the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM 5) criteria for the diagnosis of MDD

5.Ability to read Hindi or English language

6.Willing to give informed consent

7.Medication naÃ¯ve or Treatment free from prior 2 weeks or on a stable standard antidepressant regimen {including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MOAIs) or tricyclic (TCAs)} with no change in treatment 4-weeks prior to tDCS intervention

8.HAMD score >= 24 (severe depression)(Chistyakov et al., 2010; Goodman et al., 2006)

Exclusion Criteria

1.Chronic medical or neurological illness (previously diagnosed)

2.Lifetime substance use disorder (excluding tobacco or caffeine) (as per DSM-5)

3.Suffering from or any psychiatric illness other than MDD

4.Not cooperative for testing

5.Past history of significant head injury

6.Known case of intellectual disability

7.Known or suspected pregnancy or currently lactating

8.Head metal implants

9.Subjects with significant suicidal risk upon clinical assessment

10.Any history of seizure

11.Previous history of receiving any brain surgical procedures

12.Implanted metal in their body

13.Electrical or magnetic stimulation on brain in the previous three months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inter-group differences in change in scale scores (HAMD-17, MADRS and CGI).Timepoint: At baseline before beginning tDCS session and then after 10 and 20 sessions as well as after 4 weeks of last tDCS session

Secondary Outcome Measures

Name	Time	Method
Change in parameters obtained in EEG, fNIRS and MRI for correlation to symptom improvementTimepoint: At baseline before beginning tDCS session and then after 20 sessions and after 24 weeks of last tDCS session