Efficacy of oral ketamine in treatment of patients with Major depressive disorder

Efficacy of oral ketamine in treatment of patients with Major depressive disorder: A double – blind controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201608071556N93

Enrollment

Registered

2016-08-07

Start date

2016-08-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Major Depression. Major Depressive episode

Interventions

Intervention 1: Tablet sertraline up to 150 mg/day plus capsule ketamine 50 mg per day as intervention group for 6 weeks. Intervention 2: Tablet sertraline up to 150 mg/day plus placebo as control

Treatment - Drugs

Placebo

Tablet sertraline up to 150 mg/day plus capsule ketamine 50 mg per day as intervention group for 6 weeks

Tablet sertraline up to 150 mg/day plus placebo as control group for 6 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age between 18 –60 years old; moderate to severe major depressive disorder based on Diagnostic & Statistical Mental Disorders (DSM-5); HRSD score above20; signing informed consent. Exclusion criteria: receiving antidepressant drugs within the last month; cardiovascular disease; pregnancy and lactation; receiving ECT (Electroconvulsive Therapy) during the last two months; thyroid disease; alcohol & drug abuse.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Severity of depression. Timepoint: Baseline and weeks: 2, 4 and 6 after beginig of treatment. Method of measurement: Hamiltion Depression Rating Scale 17-Item.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Shahin Akhondzadeh

Tehran University of Medical Sciences

s.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

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