Intra-nasal vs. Intra-venous Ketamine Administration

Major Depressive Disorder Clinical Trial

Official title:

Intra-nasal vs. Intra-venous Ketamine Administration as an add-on to Antidepressant Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644629
• Other study ID #: SHA-15-0019
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: May 2020

Study information

• Verified date: October 2020
• Source: Shalvata Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Israel	Shalvata MHC	Hod Hasharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline		15 weeks
Secondary	Ratio of subjects achieving remission		15 weeks
Secondary	Ratio of subjects achieving Response		15 weeks
Secondary	Durability of anti-depressant effect according to MADRS Score	The rate of effect decline, as measured by MADRS Questionnaire	15 weeks
Secondary	Tolerability of Route, based on side effects questionnaire	Adverse side effects reported by subjects, as reported in side effects questionnaire	3 weeks