Clincosm LogoSign in Get a demo

Intra-nasal vs. Intra-venous Ketamine Administration

Sponsor
Shalvata Mental Health Center (Other)
Overall Status
Completed
CT.gov ID
NCT02644629
Collaborator
(none)
45
Enrollment
1
Location
2
Arms
49
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: Ketamine (1st phase)
  • Drug: Ketamine (2st phase)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Intra-nasal vs. Intra-venous Ketamine Administration as an add-on to Antidepressant Therapy
Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline [15 weeks]

    Secondary Outcome Measures

    1. Ratio of subjects achieving remission [15 weeks]

    2. Ratio of subjects achieving Response [15 weeks]

    3. Durability of anti-depressant effect according to MADRS Score [15 weeks]

      The rate of effect decline, as measured by MADRS Questionnaire

    4. Tolerability of Route, based on side effects questionnaire [3 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shalvata MHC Hod Hasharon Israel POB 94

    Sponsors and Collaborators

    • Shalvata Mental Health Center

    Investigators

    • Principal Investigator: Aviv Segev, MD, Shalvata MHC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aviv Segev, Head, Psychiatric Emergency Services, Shalvata Mental Health Center
    ClinicalTrials.gov Identifier:
    NCT02644629
    Other Study ID Numbers:
    • SHA-15-0019
    First Posted:
    Jan 1, 2016
    Last Update Posted:
    Oct 28, 2020
    Last Verified:
    Oct 1, 2020
    Additional relevant MeSH terms:
    Depressive Disorder
    Depressive Disorder, Major
    Ketamine

    Study Results

    No Results Posted as of Oct 28, 2020