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Effectiveness and safety of TDCS in depression

A randomized double-blind sham-controlled trial for evaluating effectiveness and tolerability of high-definition transcranial direct current stimulation in depression

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053834
Enrollment
20
Registered
2023-06-13
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: F332- Major depressive disorder, recurrent severe without psychotic features

Interventions

Intervention1: Active Transcranial Direct Current Stimulation: The participants in the active group will receive stimulation current at 2mA for 20 min with ramp up of 30 sec and ramp down of 30 sec in

Sponsors

All India Institute of Medical Science New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18 to 55 years 2.Any gender 3.Right-handed subjects 4.Willing to give written informed consent 5.Ability to read Hindi or English language 6.Meeting DSM 5 criteria for Major Depressive Disorder (MDD) 7.Treatment naive or Treatment free from prior 2 weeks or on a stable standard antidepressant regimen with no change in treatment 4-weeks prior to tDCS intervention 8.HAMD score >= 17 (moderate to severe depression)

Exclusion criteria

Exclusion criteria: 1. Suffering from any other psychiatric disorder or substance use disorder (except caffeine & nicotine) assessed through clinical interview using DSM 5 2. Persistent Depressive Disorder (dysthymia), Premenstrual Dysphoric Disorder, Depressive Disorder Due to Another Medical Condition, Substance/ Medication Induced Depressive Disorder, Other and Unspecified Depressive Disorders based on DSM 5 3. History of seizures 4. Pregnancy/ Lactation 5. Uncontrolled medical illness 6. History suggestive of space occupying brain lesion or cerebrovascular accident 7. Patient having implanted device or metal in brain/head or cardiac pacemaker 8. Allergic to radioligands 9. History of receiving any neuromodulation therapy (e.g., ECT, rTMS, tDCS) within the last 3-months 10. Actively suicidal as defined by a score of 4 on item 3 of HAMD 11. Currently receiving any form of Cognitive Behavioral Therapy or any other Psychotherapy

Design outcomes

Primary

MeasureTime frame
Changes in Score of Hamilton Depression Rating Scale (HAMD)Timepoint: before the first session starts, and then after 1, 2, and 4 weeks

Secondary

MeasureTime frame
Changes in Hamilton Rating Scale for Anxiety (HAMA), Trail Making Test and TDCS side effects check listTimepoint: before the first session starts, and then after 1, 2 and 4 weeks;Correlation of Baseline Cortical Activation on SPECT, BDNF gene polymorphisms, and Dexamethasone Suppression Test (DST) to change in clinical symptoms after 2 weeks assessed over HAMDTimepoint: before the first session starts;Serum BDNF levels, changes in activation and connectivity seen in fNIRS and qEEG during resting and activation state,Timepoint: before the first session starts, and then after last session (after 2 weeks)

Countries

India

Contacts

Public ContactDr Rohit Verma

All India Institute of Medical Sciences Delhi

rohit.aiims@gmail.com9868005491

Outcome results

None listed

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