Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic features
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
All India Institute of Medical Sciences Delhi