Safety and efficacy of oral ketamine versus electroconvulsive therapy in patients with major depressive disorder

Randomized controlled rater-blinded trial of the safety and efficacy of oral ketamine versus electroconvulsive therapy in patients with major depressive disorder - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082793

Enrollment

Registered

2025-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic features

Interventions

Intervention1: Oral ketamine: The intervention group will receive 6-9 sessions of thrice weekly oral ketamine over a period of 3 weeks. In the first session, ketamine will be dosed at 175 mg orally an

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of major depressive disorder without psychotic symptoms using the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria and confirmed by a consultant psychiatrist, JIPMER, Puducherry 2. Currently referred for electroconvulsive therapy (ECT) 3. No treatment with electroconvulsive therapy (ECT)for the past 6 months

Exclusion criteria

Exclusion criteria: 1. Patients with major medical or psychiatric comorbidities making them unfit for electroconvulsive therapy(ECT) 2. Patients with current alcohol or substance use disorder (except nicotine) 3. Ongoing pregnancy or lactation 4. Detection of abnormalities of concern in the electrocardiogram 5. Refusal to give informed consent

Design outcomes

Primary

Measure	Time frame
To assess the effect of thrice-weekly oral ketamine vs thrice-weekly electroconvulsive therapy(ECT), in patients with major depressive disorder, on change in depression scores at 7 days after the last ketamine/ECT session, subject to a minimum of 6 and maximum of 9 sessions of ketamine or electroconvulsive therapy(ECT)Timepoint: Patients will be assessed at baseline and 9 sessions of ketamine or electroconvulsive therapy(ECT)	—

Measure

Time frame

To assess the effect of thrice-weekly oral ketamine vs thrice-weekly electroconvulsive therapy(ECT), in patients with major depressive disorder, on change in depression scores at 7 days after the last ketamine/ECT session, subject to a minimum of 6 and maximum of 9 sessions of ketamine or electroconvulsive therapy(ECT)Timepoint: Patients will be assessed at baseline and 9 sessions of ketamine or electroconvulsive therapy(ECT)

—

Secondary

Measure	Time frame
To assess the efficacy of the first dose of oral ketamine, compared to the first session of bitemporal electroconvulsive therapy(ECT), in patients with major depressive disorder, on change in depression scores and suicidality ratingsTimepoint: Patients will be assessed at baseline, day 2, end of week 1, end of week 2, and one week after the end of treatment; that is, end of week 3;To assess the effect of thrice-weekly oral ketamine, compared to thrice-weekly electroconvulsive therapy(ECT), in patients with major depressive disorder, on suicidality ratings and global illness severity and improvement ratingsTimepoint: Patients will be assessed at baseline and at the end of each week of treatment.;To assess the effect of thrice-weekly oral ketamine, compared to thrice-weekly electroconvulsive therapy(ECT), in patients with major depressive disorder on depression scores, response and remission ratesTimepoint: Patients will be assessed at at the end of each week of treatment and 7 days after the last treatment.;To assess the effect of thrice-weekly oral ketamine, compared to thrice-weekly electroconvulsive therapy(ECT), in patients with major depressive disorder, on time to response and remission, neuropsychological test performanceTimepoint: Patients will be assessed at baseline and at 7 days after the last ketamine/electroconvulsive therapy(ECT)session.	—

Measure

Time frame

To assess the efficacy of the first dose of oral ketamine, compared to the first session of bitemporal electroconvulsive therapy(ECT), in patients with major depressive disorder, on change in depression scores and suicidality ratingsTimepoint: Patients will be assessed at baseline, day 2, end of week 1, end of week 2, and one week after the end of treatment; that is, end of week 3;To assess the effect of thrice-weekly oral ketamine, compared to thrice-weekly electroconvulsive therapy(ECT), in patients with major depressive disorder, on suicidality ratings and global illness severity and improvement ratingsTimepoint: Patients will be assessed at baseline and at the end of each week of treatment.;To assess the effect of thrice-weekly oral ketamine, compared to thrice-weekly electroconvulsive therapy(ECT), in patients with major depressive disorder on depression scores, response and remission ratesTimepoint: Patients will be assessed at at the end of each week of treatment and 7 days after the last treatment.;To assess the effect of thrice-weekly oral ketamine, compared to thrice-weekly electroconvulsive therapy(ECT), in patients with major depressive disorder, on time to response and remission, neuropsychological test performanceTimepoint: Patients will be assessed at baseline and at 7 days after the last ketamine/electroconvulsive therapy(ECT)session.

—

Countries

India

Contacts

Public ContactDr Vikas Menon

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry

drvmenon@gmail.com8098158528

Outcome results

None listed

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