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A study to find out use of Dexmedetomidine with Electroconvulsive Therapy in the improvement of depressive symptoms in adults.

The Antidepressant Effect of Dexmedetomidine with Electroconvulsive Therapy in Unipolar Depression: an Open-Label Randomized Control Trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087387
Enrollment
42
Registered
2025-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: F33- Major depressive disorder, recurrent

Interventions

Intervention1: DEXMEDETOMIDINE + ECT: Patient in the dex group will be given dexmedetomidine 0.5 mcg per kg body weight , before giving induction agent that is propofol, before the ECT procedure. 6 se

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 55 years. Sex: all genders. 2. Diagnosed primarily with depressive disorder as per ICD-10 3. American Society of Anesthesiologists (ASA) grade 2 4. Provides written informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1. Presence of significant psychiatric co-morbidities (Schizophrenia, Bipolar disorder, and obsessive-compulsive disorder). 2. Presence of significant substance use disorder (Alcohol, cannabis, opioids) other than Nicotine and caffeine. 3. Presence of organic brain conditions (Dementia, Parkinsonism, Epilepsy, brain malignancy, space-occupying lesion (SOL), Increased Intracranial Pressure, significant brain injury in the past, significant cardiovascular injuries (except lacunar infarct), 4. Mental retardation, inability to provide an informed written consent. 5. Lactation and pregnancy. 6. Medical co-morbidities: Asthma, use of beta blockers, digitalis, calcium channel blockers, congestive cardiac failure, myocardial infarction (less than 6 months). 7. A family history of reaction with the study drug is known. 8. History of any reaction or serious adverse event with the study drug. 9. Pheochromocytoma 10. HR less than 50 bpm or presence of cardiac conduction or rhythm abnormality such as sick sinus syndrome, pre-operative hypotension (SBP less than 90mmHg) 11. If ketamine is used during ECT for any reason.

Design outcomes

Primary

MeasureTime frame
The difference in HAMD 21 and C SSRS scores in dexmedetomidine and non dexmedetomidine groupTimepoint: 1)Baseline: Just Before the delivery of first session (Day 0) 2)After every 7 days that is after 3 ECT sessions . 3) After completion of ECT. ( Average ECT sessions will be 6-8 and will be decided by treating physician )

Secondary

MeasureTime frame
The difference in HAM A score and MoCA scores, and post ECT complication in dexmedetomidine and non dexmedetomidine groupTimepoint: 1)Baseline: Just Before the delivery of first session (Day 0) 2)After every 7 days that is after 3 ECT sessions . 3) After completion of ECT. 4) MoCA and post ECT complication checklist to be applied after every ECT session. ( Average ECT sessions will be 6-8 and will be decided by treating physician )

Countries

India

Contacts

Public ContactDr Ajay Kumar

AIIMS Raipur

ajaypgimer2016@gmail.com7087652595

Outcome results

None listed

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