NCT04234776

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

Intramuscular Ketamine Versus Escitalopram and Aripiprazole in Acute and Maintenance Treatment of Patients With Treatment-resistant Depression

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Depressive Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-04-03
• Primary completion: 2020-06-03
• Completion: 2021-04-03
• First posted: 2020-01-21
• Last updated: 2020-01-21

Locations

1 site across 1 country: Brazil