Intravenous versus oral Ketamine treatment for suicidality in patients with severe depression

Effect of ketamine treatment on suicidality among severely depressed patients at high risk of suicide - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075361

Enrollment

100

Registered

2024-10-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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 Health Condition 2: F322- Major depressive disorder, singleepisode, severe without psychotic features

Interventions

Intervention1: Oral Ketamine: Oral ketamine at a dose of 150 to 300 mg per session depending upon patients’ tolerability and response. A total of six sessions of alternate-day ketamine treatment over

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18 to 45 years 2. Clinically significant depressive episode as per the DSM 5 criteria (HDRS-17 total score of more than 16) 3. Moderate to High Suicidal Risk (Baseline HDRS-17 Suicide Item score of more than 2) 4. No psychotic symptoms present in the current depressive episode 5. No comorbid psychiatric disorder 6. No substance use disorder except nicotine and caffeine during past one year 7. No known or suspected contraindication to ketamine treatment

Exclusion criteria

Exclusion criteria: 1. Uncontrolled medical condition (hypertension, cardiovascular disease, cerebrovascular disease, chronic liver disease, active infections) 2. Pregnant and lactating females 3. History of receiving any neuromodulation therapy (e.g., ECT, rTMS, tDCS) within the last three months.

Design outcomes

Primary

Measure	Time frame
To assess and compare the change in suicidal ideation severity with oral and intravenous ketamine treatment in patients with depressionTimepoint: Assessment of study outcomes (HDRS-17, MSSI, HAM-A, VAS for pain, KSET) will be done at baseline, 1, 2, 4, and 6 weeks.	—

Secondary

Measure	Time frame
a)To assess and compare the change in severity of depressive symptoms, anxiety symptoms, and pain symptom with oral and intravenous ketamine treatment in patients with depressionTimepoint: Baseline, 1, 2, 4, and 6 weeks.;b)To assess and compare the frequency of adverse effects with oral and intravenous ketamine treatment in patients with depressionTimepoint: Baseline, 1, 2, 4, and 6 weeks.	—

Countries

India

Contacts

Public ContactSwarndeep Singh

VMMC and Safdarjung Hospital

sevisingh@gmail.com9650757749

Outcome results

None listed

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