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Effect of oral ketamine at doses of 1 and 2 mg/kg on depression treatment

Comparison Between the Effect of 1 & 2 mg/kg per oral Ketamine on Control and Relapse of Depressive Symptoms in Treatment-Resistant Depressed people: A Randomized, Double-Blind Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090801002266N14
Enrollment
60
Registered
2020-06-02
Start date
2020-06-21
Completion date
Unknown
Last updated
2020-06-15

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: For patients in the first group, 2 mg/kg of ketamine as a solution in a glass of fruit juice orally 2 times a week (for 6 weeks) will be prescribed. Intervention 2:

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 Individual who have DSM-V indicators for major depression without psychotic characteristics and mania or hypomania Individual who do not have an adequate response to monotherapy with antidepressants for at least two times (at least 4-6 weeks) No history of mania / hypomania Lack of psychotic symptoms Satisfaction with participating in the study

Exclusion criteria

Exclusion criteria: History of drug dependence or abuse in the last 3 months Pregnant or lactating women Serious and unstable physical patients including liver, kidney, gastrointestinal, respiratory, cardiovascular diseases (such as ischemic heart disease), endocrine, neurological, hematological. Taking medications that are contraindicated with ketamine is prohibited Untreated hypothyroidism or hyperthyroidism

Design outcomes

Primary

MeasureTime frame
Depression score. Timepoint: The second week, the fourth week and the sixth week during the intervention and one week, one month and two months after the intervention. Method of measurement: Hamilton Depressive Rating Scale (HDRS) and Beck-2 Depression Questionnaire.

Secondary

MeasureTime frame
Ketamin Side effects. Timepoint: The second week, the fourth week and the sixth week during the intervention and one week, one month and two months after the intervention. 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 3222 2127

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026