Safety and efficacy of oral Ketamine in resistant depressio

Phase 2

• Conditions: Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic featuresHealth Condition 2: F330- Major depressive disorder, recurrent, mildHealth Condition 3: F331- Major depressive disorder, recurrent, moderateHealth Condition 4: F320- Major depressive disorder, singleepisode, mildHealth Condition 5: F321- Major depressive disorder, singleepisode, moderateHealth Condition 6: F322- Major depressive disorder, singleepisode, severe without psychotic features

• Registration Number: CTRI/2023/06/054271
• Lead Sponsor: Department of psychiatry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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 <18.

5. Any other serious medical condition.

6. Any other associated psychiatric disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessing Safety & efficacy of oral ketamine in treatment resistant depressionTimepoint: 10 VISITS <br/ ><br>1st week 3 visits <br/ ><br>2nd week 3 visits <br/ ><br>3rd week 2 visits <br/ ><br>4rth week 2 visits <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Assess improvement in treatment resistant depression with active suicidal ideationTimepoint: 10 visits <br/ ><br>1st week 3 visits <br/ ><br>2nd week 3 visits <br/ ><br>3rd week 2 visits <br/ ><br>4rth week 2 visits <br/ ><br>