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Intra-nasal vs. Intra-venous Ketamine Administration

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Placebo

Ketamine (1st phase)

Ketamine (2st phase)

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Shalvata MHC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Active IV

Active IN

Arm Description

Will receive IV Ketamine, along with IN placebo.

Will receive IN Ketamine, along with IV placebo.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ratio of subjects achieving remission

Ratio of subjects achieving Response

Durability of anti-depressant effect according to MADRS Score

The rate of effect decline, as measured by MADRS Questionnaire

Tolerability of Route, based on side effects questionnaire

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

Full Information

NCT ID

NCT02644629

First Posted

December 27, 2015

Last Updated

October 27, 2020

Sponsor

Shalvata Mental Health Center

1. Study Identification

Unique Protocol Identification Number

NCT02644629

Brief Title

Intra-nasal vs. Intra-venous Ketamine Administration

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

May 2020 (Actual)

Study Completion Date

May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shalvata Mental Health Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active IV

Arm Type

Active Comparator

Arm Description

Will receive IV Ketamine, along with IN placebo.

Arm Title

Active IN

Arm Type

Active Comparator

Arm Description

Will receive IN Ketamine, along with IV placebo.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Saline 0.9%

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ketamine (1st phase)

Other Intervention Name(s)

Ketalar

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ketamine (2st phase)

Other Intervention Name(s)

Ketalar

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

15 weeks

Secondary Outcome Measure Information:

Title

Ratio of subjects achieving remission

Time Frame

15 weeks

Title

Ratio of subjects achieving Response

Time Frame

15 weeks

Title

Durability of anti-depressant effect according to MADRS Score

Description

The rate of effect decline, as measured by MADRS Questionnaire

Time Frame

15 weeks

Title

Tolerability of Route, based on side effects questionnaire

Description

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

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aviv Segev, MD

Organizational Affiliation

Shalvata MHC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shalvata MHC

City

Hod Hasharon

ZIP/Postal Code

POB 94

Country

Israel

12. IPD Sharing Statement

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Intra-nasal vs. Intra-venous Ketamine Administration

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