Overview

Intra-nasal vs. Intra-venous Ketamine Administration

Status:
Completed
Trial end date:
2020-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shalvata Mental Health Center
Treatments:
Ketamine
Criteria
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.