Efficacy of intramuscular ketamine as an adjunctive treatment in resistant unipolar depression-a double blind randomized placebo controlled study

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.