Effects of single intravenous arketamine dose as an adjunctive therapy for treatment-resistant unipolar depression: a randomized, double-blind, crossover, placebo-controlled trial

Effects of single intravenous arketamine dose as an adjunctive therapy for treatment-resistant unipolar depression: a randomized, double-blind, crossover, placebo-controlled trial - The ARKETP study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038347

Enrollment

Registered

2019-10-21

Start date

2019-08-20

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Unipolar depression

Interventions

A pilot study will be conducted with patients with unipolar depression at a dose of 0.5mg / kg. Afterwards, the randomized, double-blind, crossover, controlled study will be performed. (R)-ketamine /

that is, those who previously used (R)-ketamine will be switched to placebo, and those who receive placebo will be transferred to the active group. Pulse oximetry, heart rate, and blood pressure will

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Both genders; age between 18 to 65 years; subjects must fulfill Diagnostic and Statistical Manual of Mental Disorders 5th Edition criteria for Major Depressive Disorder, without psychotic features; initial score of at least 25 on the Montgomery Asberg Depression Rating Scale at study baseline; subjects must, at some point in their past, have failed to respond to an adequate dose and duration of at least two antidepressant trial during a current depressive episode; current depressive episode of at least 4 weeks duration.

Exclusion criteria

Exclusion criteria: Current or past diagnosis of Schizophrenia or any other psychotic disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition; subjects with a history of substance abuse disorder, according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition, within the previous 3 months; female subjects who are either pregnant or breastfeeding; serious, unstable medical illnesses; history of seizures without a clear and resolved etiology; treatment with a monoamine oxidase inhibitors within the 4 weeks prior to study; treatment with any other concomitant medication that has been disallowed; presence of any medical illness likely to alter brain morphology and/or physiology; clinically significant abnormal laboratory tests; intellectual disabilities.

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be a change in the overall MADRS score from day 1 (baseline) to day 2 (24 hours after the first infusion).	—

Countries

South America

Contacts

Public ContactLucas Quarantini

Federal University of Bahia Laboratory of Neuropsychopharmacology

lcq@ufba.br557132838076

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026