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Intra-nasal vs. Intra-venous Ketamine Administration

NCT ID: NCT02644629

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active IV

Will receive IV Ketamine, along with IN placebo.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

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

Ketamine (1st phase)

Intervention Type DRUG

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

Ketamine (2st phase)

Intervention Type 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.

Active IN

Will receive IN Ketamine, along with IV placebo.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

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

Ketamine (1st phase)

Intervention Type DRUG

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

Ketamine (2st phase)

Intervention Type 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.

Interventions

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Placebo

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

Intervention Type DRUG

Ketamine (1st phase)

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Saline 0.9% Ketalar Ketalar

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shalvata Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Aviv Segev

Head, Psychiatric Emergency Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aviv Segev, MD

Role: PRINCIPAL_INVESTIGATOR

Shalvata MHC

Locations

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Shalvata MHC

Hod HaSharon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHA-15-0019

Identifier Type: -

Identifier Source: org_study_id