Intra-nasal vs. Intra-venous Ketamine Administration

Shalvata Mental Health Center45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

PlaceboDRUG

Saline 0.9%, Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)

Ketamine (1st phase)DRUG

Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)

Ketamine (2st phase)DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shalvata MHC

Hod HaSharon, Israel

Outcomes

Primary Outcomes

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

Time frame: 15 weeks

Secondary Outcomes

Ratio of subjects achieving remission

Time frame: 15 weeks

Ratio of subjects achieving Response

Time frame: 15 weeks

Durability of anti-depressant effect according to MADRS Score

The rate of effect decline, as measured by MADRS Questionnaire

Time frame: 15 weeks

Tolerability of Route, based on side effects questionnaire

Adverse side effects reported by subjects, as reported in side effects questionnaire

Time frame: 3 weeks

Data from ClinicalTrials.gov

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