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Safety and efficacy of oral Ketamine in resistant depression

A randomized double blind placebo controlled study on safety and efficacy of oral Ketamine in patients of Treatment Resistant Depression - NILL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054271
Enrollment
60
Registered
2023-06-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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: F330- Major depressive disorder, recurrent, mild Health Condition 3: F331- Major depressive disorder, recurrent, moderate Health Condition 4: F320- Major depressive disorder, singleepisode, mild Health Condition 5: F321- Major depressive disorder, singleepisode, moderate Health Condition 6: F322- Major depressive disorder, singleepisode, severe without psychotic features

Interventions

Intervention1: ORAL KETAMINE (5O MG/ 1 ML VIAL): Dose of 1.5 mg /kg of ketamine will be given in 150ml of Paper boat juice ( apple flavour) 9 doses over 1 month Control Intervention1: DISTILLED WATER:

Sponsors

Department of psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All participants who have not responded adequately to therapeutic trials of 2 antidepressants of different classes given in adequate dose for 6 weeks. 2. Participants should be on stable medication of antidepressants for a period of at least 6 weeks. 3. Able to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Participants who have taken Ketamine treatment (in any route) for depression before. 2. Participants having any known gastrointestinal issues or oral ulcers or diseases. 3. Pregnant participants. 4. Participants with age 5. Any other serious medical condition. 6. Any other associated psychiatric disorder.

Design outcomes

Primary

MeasureTime frame
Assessing Safety & efficacy of oral ketamine in treatment resistant depressionTimepoint: 10 VISITS 1st week 3 visits 2nd week 3 visits 3rd week 2 visits 4rth week 2 visits

Secondary

MeasureTime frame
Assess improvement in treatment resistant depression with active suicidal ideationTimepoint: 10 visits 1st week 3 visits 2nd week 3 visits 3rd week 2 visits 4rth week 2 visits

Countries

India

Contacts

Public ContactDR Drashti Shah

GMERS Medical College and Hospital Gotri

hod.psy.gotri@gmail.com8320463150

Outcome results

None listed

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