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A trial to look for effect of supplemental High-Definition Transcranial Direct Current Stimulation in Treatment of Depression

Effect of Adjunctive High-Definition Transcranial Direct Current Stimulation in Treatment of Depression- A Double Blinded Randomized Sham-Controlled Study - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062752
Enrollment
50
Registered
2024-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic features Health Condition 2: F331- Major depressive disorder, recurrent, moderate Health Condition 3: F32- Major depressive disorder, singleepisode

Interventions

Intervention1: High Definition Transcranial Direct Current Stimulation[HDtDCS]: • Active HD-tDCS group: will receive 10 sessions (1 per day) over 2 weeks
2mA current and for 20 minutes in each session that is spaced over at least 24 hours. The anode will be placed over the left DLPFC, which is located at F3 based on the 10/20 electroencephalogram syst
0.2mA current and for 20 minutes in each session that is spaced over at least 24 hours. The anode will be placed over the left DLPFC, which is located at F3 based on the 10/20 electroencephalogram sys

Sponsors

Paramjeet Singh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 50 years 2) Sex: male or female 3) Diagnosis of depression (F32, F33) as per ICD-10-DCR 4) Score of 14 or above on HAM-D 5) Provides written informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1) Presence of any other psychiatric disorder, organic mental disorder, or mental retardation. 2) Known substance dependence other than caffeine or nicotine. 3) Presence of suicide attempts, high risk for suicide, psychotic symptoms or catatonia in current episode 4) Presence of unstable medical condition requiring urgent priority management 5) Has received electro-convulsive therapy or any other neuro-stimulation in last three months 6) Patients with metal in cranium, pacemaker in-situ, history of significant traumatic brain injury, epilepsy or cerebrovascular accident 7) Pregnant or breast-feeding mothers 8) Presence of skin problems, such as dermatitis, psoriasis or eczema over the scalp 9) History of serious adverse event following transcranial electric or magnetic stimulation in the past.

Design outcomes

Primary

MeasureTime frame
The difference in HDRS scores in active and sham groupTimepoint: Baseline: Just before the delivery of first session (Day 0) • After completion of 10 sessions of HD-tDCS.

Secondary

MeasureTime frame
1. Difference in HDRS score after four weeks of last session of HD-tDCS 2. Difference in HAM-A, MOCA & GAF scores.Timepoint: 1. For HDRS: 4 weeks from last session 2. For HAM-A, MOCA & GAF, after ten sessions of HD-tDCS & after 4 weeks from the day of last session

Countries

India

Contacts

Public ContactParamjeet Singh

AIIMS , RAIPUR

singhlokesh123@aiimsraipur.edu.in8103624062

Outcome results

None listed

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