Intra-nasal vs. Intra-venous Ketamine Administration

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

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 Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Ketamine (1st phase); Drug: Ketamine (2st phase)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Hod Hasharon, Israel, POB 94
    • Shalvata MHC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active IV; Will receive IV Ketamine, along with IN placebo.	Drug: Placebo; Saline 0.9%, Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils); Other Names: Saline 0.9%; Drug: Ketamine (1st phase); Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils); Other Names: Ketalar; 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.; Other Names: Ketalar
Active Comparator: Active IN; Will receive IN Ketamine, along with IV placebo.	Drug: Placebo; Saline 0.9%, Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils); Other Names: Saline 0.9%; Drug: Ketamine (1st phase); Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils); Other Names: Ketalar; 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.; Other Names: Ketalar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline	15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of subjects achieving remission		15 weeks
Ratio of subjects achieving Response		15 weeks
Durability of anti-depressant effect according to MADRS Score	The rate of effect decline, as measured by MADRS Questionnaire	15 weeks
Tolerability of Route, based on side effects questionnaire	Adverse side effects reported by subjects, as reported in side effects questionnaire	3 weeks

Collaborators and Investigators

• Sponsor: Shalvata Mental Health Center
• Investigators: Principal Investigator: Aviv Segev, MD, Shalvata MHC

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: December 27, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): January 1, 2016

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: SHA-15-0019