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Intra-nasal vs. Intra-venous Ketamine Administration

NCT02644629 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-10-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Shalvata Mental Health Center

    lead OTHER

Principal Investigators

  • Aviv Segev, MD · Shalvata MHC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02644629 on ClinicalTrials.gov