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ketamine injection on improving treatment-resistant depression

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090801002266N22
Enrollment
52
Registered
2026-02-09
Start date
2026-04-04
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment-Resistant Major Depressive Disorder. Major depressive disorder, recurrent, unspecified

Interventions

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 grou

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGholamreza Kheirabadi

Esfahan University of Medical Sciences

kheirabadi@bsrc.mui.ac.ir+98 31 3303 3740

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026