A Clinical trial to study the efficacy and safety of Ketamine on patient with Severe depression.

Phase 3

Not yet recruiting

Conditions: Major depressive disorder, singleepisode, moderate, (2) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, (3) ICD-10 Condition: F323||Major depressive disorder, singleepisode, severe with psychotic features, (4) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (5) ICD-10 Condition: F333||Major depressive disorder, recurrent, severe with psychotic symptoms,

Registration Number: CTRI/2021/10/037627

Lead Sponsor: KIMS

Brief Summary: This is Randomised controlled trial studing safety and efficacy of add on Ketamine in patient of severe Depression.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 52

Inclusion Criteria

Patients diagnosed with severe depression according to the DSM-5 guidelines and ham-d score suggesting Depression.
Patients who give their consent.

Exclusion Criteria

1.Patients with present diagnosis or antecedents of clinically relevant cardiovascular disorder such as stroke, heart attack,etc 2.Patients with present or past diagnosis of glaucoma, intracranial hypertension 3.Patients with current diagnosis of schizophrenia and related disorder 4.Significant ECG abnormalities 5.History of neurological disease or prior head trauma with evidence of cognitive impairment 6.Known hypersensitivity to ketamine 7.Patients who donot give their informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome of treatment will be measured in terms of reduction of the HAM-D score by more than 50%	by at the end of two weeks

Secondary Outcome Measures

Name	Time	Method
Reduction in the score of suicidal risk	Improvement in the global functioning

Trial Locations

Locations (1): Kalinga institute of medical sciences
🇮🇳
Khordha, ORISSA, India
Kalinga institute of medical sciences
🇮🇳Khordha, ORISSA, India
Dr Anand Prakash
Principal investigator
7667683640
dr.anandprakash24@gmail.com