A clinical trial to study the effect of drug Ketamine, given by oral route, in the patients with depression and suicidal ideation.

A randomized placebo-controlled trial for evaluating effectiveness and tolerability of oral Ketamine augmentation for moderate to severe major depressive disorder with suicidality. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075680

Enrollment

Registered

2024-10-23

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: F321- Major depressive disorder, singleepisode, moderate Health Condition 2: F322- Major depressive disorder, singleepisode, severe without psychotic features

Interventions

Intervention1: oral ketamine: Active group will receive oral ketamine hydrochloride (2.5mg/kg mixed in flavoured agent) sipped over 10 to 15 mins in one session. Control Intervention1: Normal saline:

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 or comprehend 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, including selective serotonin reuptake inhibitors, serotonin-noradrenaline reuptake inhibitors, monoamine oxidase inhibitors or tricyclic antidepressants, with no change in treatment in previous 4 weeks. 8. HAMD score =17 (moderate to severe depression) 9. Having current suicidal ideation as defined by HAMD score =2 for item no. 3 (assessing suicidal ideation) 10. Refusing modified electroconvulsive therapy

Exclusion criteria

Exclusion criteria: 1. Suffering from psychotic symptoms or other psychiatric disorder or substance use disorder (except caffeine & nicotine) assessed clinically 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 (including hypertension) 6. History suggestive of space occupying brain lesion or cerebrovascular accident 7. Prescribed new antidepressants for treatment of MDD on the day of screening/recruitment 8. Prescription of any antipsychotic medication or mood stablizers 9. History of receiving any neuromodulation therapy (e.g., ECT, rTMS, tDCS) within the last 3-months. 10. Currently receiving any form of cognitive behavioral therapy or any other psychotherapy.

Design outcomes

Primary

Measure	Time frame
Changes in HAMD, HAMA, KSET and MSSI scores within active (oral ketamine) group & placebo group and comparison between both the groups of the sameTimepoint: At baseline, 1 week and 2 weeks post intervention	—

Secondary

Measure	Time frame
To compare the change in serum BDNF levels, prefrontal hemodynamic activity (using fNIRS) and spectral/ERP changes (using qEEG) in individuals with depression having suicidal ideation after adjunctive treatment with oral ketamine or placebo.Timepoint: At baseline and at 2 weeks	—

Countries

India

Contacts

Public ContactPranjal Kabra

All India Institute of Medical Sciences New Delhi

pratapsharan@gmail.com9868216356

Outcome results

None listed

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