Investigating the effect of adding subcutaneous ketamine to routine treatment of treatment-resistant depressed patients

1.Determination and Comparison of mean depression scores between intervention and control groups before the intervention, at weeks 2, 4, 6, and one month after the last session. 2.Determination and Comparison of the mean number of adverse events between intervention and control groups at the same time points.

A clinical trial with control group, with the parallel groups, Double-blind, randomized

in a double-blind clinical trial at Khorshid Hospital in Isfahan enrolls 52 patients with treatment-resistant major depressive disorder, who are randomly assigned to two parallel groups. Depression severity and adverse effects are evaluated at baseline, during weeks 2, 4, and 6 of treatment, and one month after the final intervention.

Inclusion criteria: 1.Age between 60-18 years 2.Individual who have DSM-V indicators for major depression without psychotic characteristics and mania or hypomania 3.Individual who do not have an adequate response to monotherapy with antidepressants for at least two times (at least 4-6 weeks) 4.Satisfaction with participating in the study Exclusion criteria: 1.Pregnant or breastfeeding women 2.History of substance dependence or abuse in the last 3 months 3.Serious and unstable physical patients 4.Untreated hypothyroidism or hyperthyroidism 5.Current or past history of psychotic symptoms 6.History of mania or hypomania, catatonia, or depression secondary to a medical condition 7.History of hypertension 8.History of seizure disorder 9. renal failure

In the intervention group, ketamine(0.5 mg/kg) is administered subcutaneously, and in the control group, normal saline is administered subcutaneously, both twice weekly for six weeks

severity of depression؛ side effects

Eligible participants will be randomized using block randomization with a block size of two. Within each block, participants are ordered by national ID number. A random number table is used to determine the allocation sequence. Two possible sequences exist (A-B,B-A) , and neither participants nor investigators know which label(A orB) corresponds to ketamin or placebo . A third party who is aware of the treatment codes prepares the study medications in sealed opaque envelopes and delivers them to the research team, maintaining double blinding. This process continues until all participants have received their assigned intervention.

Both participants and investigators involved in outcome assessment are unaware of the treatment assignments. Study medications, labeled as A and B, are prepared by a third party who is not involved in patient evaluation. The third party is aware of the correspondence between the labels and the actual interventions (drug or placebo). The medications are placed in sealed opaque envelopes and delivered to the research team for administration. Blinding is maintained until all study outcomes have been collected.

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