A clinical trial to assess the effectiveness of ketamine when used with antidepressants in moderate to severe depressive episode

Ketamine as an adjuvant to antidepressants in moderate to severe unipolar depression: A randomised clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082605

Enrollment

Registered

2025-03-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: F32- Major depressive disorder, singleepisode

Interventions

Intervention1: IV ketamine infusion along with oral antidepressants: 0.5 mg/kg of ketamine is diluted in 100ml normal saline and given over a period of 40 minutes. Total 4 cycles of ketamine infusion

Eligibility

Inclusion criteria

Inclusion criteria: Male or female patients in the age group of 18 to 65 years Subjects who agree to sign an informed consent document Subjects diagnosed with moderate or severe depression by a qualified psychiatrist according to ICD 10 or ICD 11 Subjects having an initial score of more than 20 on the Montgomery Asberg Depression Rating Scale Subjects with or without history of suicide attempts in current episode Subjects with or without co-morbid anxiety, panic or obsessive compulsive symptoms

Exclusion criteria

Exclusion criteria: Subjects of age more than 65 years Subjects with history of bipolar depression Subjects with psychotic symptoms Subjects with pre-existing cognitive impairment or mental retardation Subjects with history of hypersensitivity to ketamine Pregnant and breastfeeding women Subjects with history of substance use (except nicotine and/or caffeine)

Design outcomes

Primary

Measure	Time frame
To assess the onset of response and effectiveness of ketamine as an adjuvant to oral antidepressants in moderate to severe unipolar depression.Timepoint: Baseline, after 24 hours, 2 weeks and 4 weeks	—

Secondary

Measure	Time frame
To assess improvement in symptoms using Montgomery Asberg Depression Rating Scale (MADRS) scores in both study groups.Timepoint: Baseline, after 24 hours, 2 weeks & 4 weeks;To assess the risk of suicidal intent using Columbia- Suicide Severity Rating Scale (C-SSRS) & response to treatment in both study groups. Timepoint: Baseline, after 24 hours, 2 weeks & 4 weeks	—

Countries

India

Contacts

Public ContactDR SHRUTHI NANDAKUMAR

Shri BM Patil Medical College, Hospital and Research centre, BLDE(DU)

santoshramdurg@gmail.com9611281386

Outcome results

None listed

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