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Intra-nasal vs. Intra-venous Ketamine Administration

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ClinicalTrials.gov Identifier: NCT02644629
Recruitment Status : Recruiting
First Posted : January 1, 2016
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Aviv Segev, Shalvata Mental Health Center

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
Major Depressive Disorder Drug: Placebo Drug: Ketamine (1st phase) Drug: Ketamine (2st phase) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : April 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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 Name: Saline 0.9%

Drug: Ketamine (1st phase)
Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)
Other Name: 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 Name: 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 Name: Saline 0.9%

Drug: Ketamine (1st phase)
Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)
Other Name: 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 Name: Ketalar




Primary Outcome Measures :
  1. MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline [ Time Frame: 15 weeks ]

Secondary Outcome Measures :
  1. Ratio of subjects achieving remission [ Time Frame: 15 weeks ]
  2. Ratio of subjects achieving Response [ Time Frame: 15 weeks ]
  3. Durability of anti-depressant effect according to MADRS Score [ Time Frame: 15 weeks ]
    The rate of effect decline, as measured by MADRS Questionnaire

  4. Tolerability of Route, based on side effects questionnaire [ Time Frame: 3 weeks ]
    Adverse side effects reported by subjects, as reported in side effects questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644629


Contacts
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Contact: Aviv Segev, MD +972-9-7478-638 aviv.segev@clalit.org.il

Locations
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Israel
Shalvata MHC Recruiting
Hod Hasharon, Israel, POB 94
Contact: Aviv Segev, MD    +972-9-7478-638    aviv.segev@clalit.org.il   
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
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Principal Investigator: Aviv Segev, MD Shalvata MHC

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Responsible Party: Aviv Segev, Head, Psychiatric Emergency Services, Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT02644629     History of Changes
Other Study ID Numbers: SHA-15-0019
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action