Effectiveness of intramuscular ketamine with other treatment of resistance unipolar depression patients

Recruiting

Conditions: Major depressive disorder, singleepisode,

Registration Number: CTRI/2023/05/053136

Lead Sponsor: Institute of Postgraduate Medical Education and Research

Brief Summary: BACKGROUND OF PRESENT STUDY- In recent times lots of study were conducted where Ketamine was administered through Intra venous route in target population but there are very few studies where it was administered via Intramuscular route. In a recent study it was found that Intramuscular ketamine in the dose of 0.25 mg/kg is as effective and safe as 0.5 mg/kg given either I.M. or I.V., substantially alleviating depressive symptoms within a few hours and sustained for 3 days. In order to explore feasibility of IM Ketamine as adjunctive therapy in cases of treatment resistant depression patients, we will conduct this study.

OBJECTIVE- To compare the treatment response between two groups of patients with treatment resistant depression; One group with conventional pharmacotherapy and the group with conventional pharmacotherapy along with adjunctive intramuscular ketamine.

METHODOLGY: A double blind randomised placebo controlled study will be conducted with 60 patients.All the patienet will be admitted in IOP indoor facility after fulfilling inclusion and exclusion criteria. Patients will be divided into 30 patients in each group by block randomisation and one group will get Intramuscular ketamine and another group will get normal saline as placebo along with oral medication. All the patient will be assessed by MADRS scale on day 0,7th, 14th,30th day and data will be collected and will be analysed. Assesment will be done by different psychiatrist who will not aware about the patient’s treatment protocol.

EXPECTED OUTCOME-The group who will receive Intramuscular ketamine as adjuvant treatment will show better response than the group who will get normal saline as adjuvant.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 60

Inclusion Criteria

Resistant uni-polar depression patients.
patients who have diagnosed major depressive disorder according to ICD 10 by two different psychiatrist & patient who already received maximum dose of two antidepressant for 6-8 weeks.

Exclusion Criteria

Current substance abuse 2.mental retardation, pervasive developmental disorder 3.
epilepsy and other neurological disorder 4.
hypertension and other.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients receiving intramuscular ketamine as adjuvant treatment will show better response than the patients receiving placebo	1.5 Years

Secondary Outcome Measures

Name	Time	Method
If there is any improvement in suicidal ideation	1.5yrs

Trial Locations

Locations (1): Institute of Psychiatry-COE
🇮🇳
Kolkata, WEST BENGAL, India
Institute of Psychiatry-COE
🇮🇳Kolkata, WEST BENGAL, India
Deborshi Das
Principal investigator
7003423081
deborshimedico@gmail.com