NCT02644629

Intra-nasal vs. Intra-venous Ketamine Administration

Intra-nasal vs. Intra-venous Ketamine Administration as an add-on to Antidepressant Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Shalvata Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The current study wishes to contribute to the applicability of the use of ketamine in a clinical setting by focusing on the efficacy of intra-nasal administration compared with the IV route.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Saline 0.9%, Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)
DRUG	Ketamine (1st phase)	Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)
DRUG	Ketamine (2st phase)	Patients failing to achieve response (\<50% MADRS score) in the parallal phase, will be offered additional 4 session (twice a week, 2 weeks) of 0.5 mg/kg ketamine over 40 minutes.

Timeline

• Start date: 2016-04-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2016-01-01
• Last updated: 2020-10-28

Locations

1 site across 1 country: Israel