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Use of brain stimulation for treatment of Depression

A randomized controlled trial of the effectiveness of Transcranial Direct Current Stimulation (tDCS) for Treatment of Major Depression

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050546
Enrollment
20
Registered
2023-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Active Transcranial Direct Current Stimulation (tDCS): The participants will receive stimulation current at 2mA for 20 min with ramp up of 30 sec and ramp down of 30 sec in a single ses

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

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 naïve 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactRohit Verma

All India Institute of Medical Sciences

rohit.aiims@gmail.com09868005491

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026