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CompletedPhase 4

Intra-nasal vs. Intra-venous Ketamine Administration

NCT02644629 · Shalvata Mental Health Center

Closed to entry
Status
Not accepting participants
Phase 4
Phase
45
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline

    Measured over 15 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Age 18-65 2. Diagnosis of MDD (Major Depressive Disorder), made or affirmed by a senior psychiatrist in Shalvata 3. MADRS score \> 20 4. Treated with conventional anti-depressant, administered within a formal psychiatric clinic or by a certified psychiatrist. Exclusion Criteria: 1. Active or past psychotic disorder, including a history of psychotic affective state 2. Mental Retardation or Autistic Spectrum Disorder 3. Prominent personality disorder 4. Cardiac or neurologic active medical condition, including past CVA/TIA (Cardiovascular Accident/Transient Ischemic Attack) or any other unstable medical condition. 5. Chronic nasal congestion 6. Active or recent drug or alcohol abuse 7. Substantial suicidality in a patient requiring admission but refuses to do so, and signs an "against medical advice" release form as part of clinical evaluation, and does not answer the terms for involuntary admission.

Where

1 study site

FacilityCityRegionCountry
Shalvata MHCHod HaSharonIsrael

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02644629 on ClinicalTrials.gov →

Last updated in the registry 2020-10-28. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits