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IRCT20090801002266N22 IRCT 2026-02-09 Esfahan University of Medical Sciences ketamine injection on improving treatment-resistant depression Investigating the effect of adding subcutaneous ketamine to routine treatment of treatment-resistant depressed patients 2026-04-04 anticipated 52 Recruiting https://irct.ir/trial/88903 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Treatment-Resistant Major Depressive Disorder. Intervention 1: Intervention group: In this group, ketamine at a dose of 0.5 mg/kg is administered subcutaneously twice weekly for six weeks, for a total of 12 injections. Intervention 2: Control group: n this group, Placebo (normal saline) is administered subcutaneously twice weekly for six weeks, for a total of 12 injections. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Gholamreza Kheirabadi
Ostandari
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3303 3740 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences scientific Gholamreza Kheirabadi
Department of psychiatry, Khorshid hospital, Ostandari St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3303 3740 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 60-18 years Individuals who have DSM-V indicators for major depression without psychotic characteristics and mania or hypomania individuals who do not have an adequate response to monotherapy with antidepressants for at least two times (at least 4-6 weeks) Satisfaction with participating in the study 18 years 60 years Both Pregnant or breastfeeding women History of substance dependence or abuse in the last 3 months Serious and unstable physical patients including liver, kidney, gastrointestinal, respiratory, cardiovascular diseases (such as ischemic heart disease), endocrine, neurological, hematological Untreated hypothyroidism or hyperthyroidism Current or past history of psychotic symptoms History of mania or hypomania, catatonia, or depression secondary to a medical condition History of hypertension History of seizure disorder Diagnosis of renal failure F33.9 Major depressive disorder, recurrent, unspecified Treatment - Drugs Placebo Intervention group: In this group, ketamine at a dose of 0.5 mg/kg is administered subcutaneously twice weekly for six weeks, for a total of 12 injections. Control group: n this group, Placebo (normal saline) is administered subcutaneously twice weekly for six weeks, for a total of 12 injections. Depression score (assessed using the HDRS). Timepoint: Before the intervention, at week 2, week 4, and week 6 during the intervention, and one month after the last intervention session. Method of measurement: Hamilton Depressive Rating Scale (HDRS). Intervension side effects. Timepoint: Before the intervention, at week 2, week 4, and week 6 during the intervention, and one month after the last intervention session. Method of measurement: checklist evaluation. Esfahan University of Medical Sciences Approved 2026-01-27 Research Ethics Committee of School of Medicine ,Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib street lsfahan Isfehan Iran (Islamic Republic of)