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Evaluation of medication response in individuals having depressive disorder using blood test and brain activity and comparing them to healthy individuals

A longitudinal observational study to evaluate antidepressant medication response using brain derived nerve growth factor and cortical hemodynamic and electrical activity - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/09/057824
Enrollment
60
Registered
2023-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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: Anti depressant medication: Clinician decided anti depressant medication will be provided. Investigator will not change or suggest any medication.

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria – MDD group 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 naïve or Treatment free from prior 2 weeks or on a stable standard antidepressant regimen with no change in treatment in previous 4-weeks. 8. Prescribed antidepressants for treatment of MDD on the day of screening/recruitment 9. HAMD score = 17 (moderate to severe depression) (Zimmerman et al., 2013) Inclusion criteria – Healthy controls 1. Age (18 to 55 years) matched (± 5 years) and Gender matched 2. Right-handed 3. Willing to give written informed consent 4. Ability to read Hindi or English language 5. Not suffering from any psychiatric illness (on clinical evaluation)

Exclusion criteria

Exclusion criteria: 1. Suffering from any psychotic symptoms or other psychiatric disorder or substance use disorder (except caffeine & nicotine) 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. Current prescription or history within last 3-months of receiving any Psychotherapy/Neuromodulation 8. Actively suicidal as defined by a score of 4 on item 3 of HAMD

Design outcomes

Primary

MeasureTime frame
Change in HAMD scores & cortical activity within patient group & comparison of cortical activity between patient group & healthy groupTimepoint: at baseline & after 4 & 8 weeks

Secondary

MeasureTime frame
BDNF gene polymorphism correlation with depression severityTimepoint: baseline

Countries

India

Contacts

Public ContactRohit Verma

All India Institute of Medical Sciences New Delhi

rohit.aiims@gmail.com9868005491

Outcome results

None listed

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