Intra-nasal vs. Intra-venous Ketamine Administration

• ClinicalTrials.gov Identifier: NCT02644629
• Recruitment Status: Completed
• First Posted: January 1, 2016
• Last Update Posted: October 28, 2020
• Sponsor: Shalvata Mental Health Center
• Information provided by (Responsible Party): Aviv Segev, Shalvata Mental Health Center

Tracking Information

• First Submitted Date: December 27, 2015
• First Posted Date: January 1, 2016
• Last Update Posted Date: October 28, 2020
• Study Start Date: April 2016
• Actual Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 30, 2015): MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline [ Time Frame: 15 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 30, 2015)

• Ratio of subjects achieving remission [ Time Frame: 15 weeks ]
• Ratio of subjects achieving Response [ Time Frame: 15 weeks ]
• Durability of anti-depressant effect according to MADRS Score [ Time Frame: 15 weeks ]
  The rate of effect decline, as measured by MADRS Questionnaire
• Tolerability of Route, based on side effects questionnaire [ Time Frame: 3 weeks ]
  Adverse side effects reported by subjects, as reported in side effects questionnaire

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

• 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

Study Arms

• Active Comparator: Active IV
  Will receive IV Ketamine, along with IN placebo.
  Interventions:

  • Drug: Placebo
  • Drug: Ketamine (1st phase)
  • Drug: Ketamine (2st phase)
• Active Comparator: Active IN
  Will receive IN Ketamine, along with IV placebo.
  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 27, 2020): 45
• Original Estimated Enrollment (submitted: December 30, 2015): 60
• Actual Study Completion Date: May 2020
• Actual Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT02644629
• Other Study ID Numbers: SHA-15-0019
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Aviv Segev, Shalvata Mental Health Center
• Original Responsible Party: Aviv Segev, Shalvata Mental Health Center, Deputy Director, Psychiatric Emergency Services
• Current Study Sponsor: Shalvata Mental Health Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Aviv Segev, MD; Shalvata MHC

• PRS Account: Shalvata Mental Health Center
• Verification Date: October 2020