Intra-nasal vs. Intra-venous Ketamine Administration

NCT02644629 | Completed Phase 4 DMC

• 1 other identifier: SHA-15-0019
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

  15 weeks

Secondary Outcomes (4)

• Ratio of subjects achieving remission

  15 weeks

• Ratio of subjects achieving Response

  15 weeks

• Durability of anti-depressant effect according to MADRS Score

  15 weeks

• Tolerability of Route, based on side effects questionnaire

  3 weeks

Study Arms (2)

Active IV

ACTIVE COMPARATOR

Will receive IV Ketamine, along with IN placebo.

Drug: Placebo; Drug: Ketamine (1st phase); Drug: Ketamine (2st phase)

Active IN

ACTIVE COMPARATOR

Will receive IN Ketamine, along with IV placebo.

Drug: Placebo; Drug: Ketamine (1st phase); Drug: Ketamine (2st phase)

Interventions

Placebo DRUG

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

Also known as: Saline 0.9%

Active IN; Active IV

Ketamine (1st phase) DRUG

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

Also known as: Ketalar

Active IN; Active IV

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.

Also known as: Ketalar

Active IN; Active IV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Diagnosis of MDD (Major Depressive Disorder), made or affirmed by a senior psychiatrist in Shalvata
• MADRS score \> 20
• Treated with conventional anti-depressant, administered within a formal psychiatric clinic or by a certified psychiatrist.

You may not qualify if:

• Active or past psychotic disorder, including a history of psychotic affective state
• Mental Retardation or Autistic Spectrum Disorder
• Prominent personality disorder
• Cardiac or neurologic active medical condition, including past CVA/TIA (Cardiovascular Accident/Transient Ischemic Attack) or any other unstable medical condition.
• Chronic nasal congestion
• Active or recent drug or alcohol abuse
• 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.

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Shalvata MHC

Hod HaSharon, POB 94, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Sodium Chloride; Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Aviv Segev, MD

  Shalvata MHC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Psychiatric Emergency Services

Study Record Dates

• First Submitted: December 27, 2015
• First Posted: January 1, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

IL (1)