Skip to content

COMPARATIVE STUDY OF ESKETAMINE AND RACEMIC KETAMINE IN TREATMENT-RESISTANT DEPRESSION: A RANDOMIZED, DOUBLE-BLIND, NON-INFERIORITY TRIAL

COMPARATIVE STUDY OF ESKETAMINE AND RACEMIC KETAMINE IN TREATMENT-RESISTANT DEPRESSION: A RANDOMIZED, DOUBLE-BLIND, NON-INFERIORITY TRIAL - COMPARATIVE STUDY OF ESKETAMINE AND RACEMIC KETAMINE IN TRD

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032355
Enrollment
68
Registered
2018-05-01
Start date
2017-01-01
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

Treatment Resistant Depression

Interventions

Esketamine Racemic ketamine

Sponsors

HUPES - Hospital Universitario Professor Edgard Santos
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All volunteers enrolled in the study must comply with all of the following at the time of the randomization: -Have the diagnosis of MDD confirmed by the Brazilian version of the Mini International Neuropsychiatric Interview 5.0.0 (MINI-Plus) (Amorim, 2000) applied by experienced and properly trained evaluators. -Be diagnosed with TRD, characterized by therapeutic failure after at least one adequate antidepressant treatment for at least 12 weeks. -Be 18 years or older

Exclusion criteria

Exclusion criteria: -Patients who have been submitted to ECT -Diagnosis of a psychotic disorder -Mental retardation or dementia (except for patients with such diagnoses who have a family member or a responsible person who may sign their informed consent form) -Decompensated heart disease -Illicit drug users.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the difference in remission rates of depressive symptoms between the two treatment arms at 24 and 72 hours. Remission is defined as a MADRS score of 7 or less.

Countries

South America

Contacts

Public ContactFernanda Santana Correia de Melo

Universidade Federal da Bahia Department of Psychiatry

fernandascorreia@hotmail.com557132838100

Outcome results

None listed

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