Intramuscular Ketamine Versus Aripiprazole and Escitalopram in the Treatment of Resistant Depression

Last updated on July 2021

Recruitment

Recruitment Status: Enrolling by invitation
Estimated Enrollment: Same as current

Summary

Conditions: Depressive Disorder
Type: Interventional
Phase: Phase 4
Design: Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects will receive IM ketamine or IM saline applications as randomized. Applications will occur three times a week. It will be 4 weeks of IM application (12 initial applications). Injections will occur into the subjects' glutes (0.75 mg / kg). The ketamine group will use 2 placebo tablets and the parallel group escitalopram 15 mg and aripiprazole 5 mg. Thereafter, participants will receive weekly ketamine doses over 6 months as maintenance treatment. Research members will be submitted to Structured Clinical Interview for the DSM for diagnostic categorization and will be evaluated from other scales. Vital signs will be checked continuously for a period of 2 hours with each infusion. Patients will be observed in a quiet, comfortable room and subjected to medical monitoring for 2 hours. They will leave the environment in the company of a competent adult.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 40 years
Gender: Both males and females

Description

Compare the response of ketamine IM versus active control in treatment-resistant depression (TRD [primary outcome]) and find safety and tolerability of ketamine IM, evaluate changes in life quality, cognition and suicidal risk (secondary outcomes)

Tracking Information

NCT #: NCT04234776
Collaborators: Not Provided
Investigators: Principal Investigator: Ricardo A Moreno, MD, PhD Department and Institute of Psychiatry, University of Sao Paulo