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

Summary

The treatment of resistant depression should be optimized aiming at complete remission of symptoms, a complex condition due to several factors. Approximately 1/3 of patients with depressive disorders do not even respond to available antidepressants. Consequently, new molecules with robust action, fast effects and sustained improvement are currently being researched worldwide. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has emerged as a promising alternative due to its involvement in neurogenesis, synaptogenesis and consequent rapid improvement of depressive and suicidal symptoms with traditional intravenous (IV) use in sub dose (0.5 mg / kg). The therapeutic response of IV use has been short and requires monitoring in a hospital setting. There are no studies evaluating response to long-term ketamine use. Recent research has focused on identifying other routes of ketamine use such as intranasal and intramuscular (IM). The use of ketamine IM, despite the fact that there are few studies and small samples, can demonstrate efficacy in acute treatment and maintenance of depression, as well as low profile of side effects, greater accessibility potential, reduced costs and risks, patient comfort and possible expansion of resistant depression treatment capabilities in different settings.

Conditions

• Depressive Disorder

Interventions

DRUG

Ketamine

(0,75 mg/kg) saline solution (15 mg) Escitalopram (5 mg) Aripiprazole

DIAGNOSTIC_TEST

Cognition

Composite tools

OTHER

Suicide risk

MADRS (10) and HAM-D (3)

OTHER

Depression thoughts

EPD

OTHER

Quality of life and disability

Quality of life and disability

OTHER

Clinical and epidemiological factors

Variables and categories

DEVICE

Safety of ketamine IM

Vital signs

OTHER

Tolerability of ketamine IM

UKU-SERS, YOUNG, CADSS and BPRS-12.

Sponsors & Collaborators

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Ricardo A Moreno, MD, PhD · Department and Institute of Psychiatry, University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-03

Primary Completion

2020-06-03

Completion

2021-04-03

Countries

• Brazil

Study Locations