Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intra-nasal vs. Intra-venous Ketamine Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE December 27, 2015
First Posted Date  ICMJE January 1, 2016
Last Update Posted Date April 19, 2018
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2015)
MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline [ Time Frame: 15 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02644629 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-nasal vs. Intra-venous Ketamine Administration
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 30, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aviv Segev, MD +972-9-7478-638 aviv.segev@clalit.org.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02644629
Other Study ID Numbers  ICMJE SHA-15-0019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aviv Segev, Shalvata Mental Health Center
Study Sponsor  ICMJE Shalvata Mental Health Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aviv Segev, MD Shalvata MHC
PRS Account Shalvata Mental Health Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP