Intra-nasal vs. Intra-venous Ketamine Administration

Phase 4

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: Ketamine (1st phase); Drug: Ketamine (2st phase)

• Registration Number: NCT02644629
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-27
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2016-01-01
• Study Start: 2016-04
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active IN	Ketamine (2st phase)	Will receive IN Ketamine, along with IV placebo.
Active IV	Ketamine (1st phase)	Will receive IV Ketamine, along with IN placebo.
Active IN	Placebo	Will receive IN Ketamine, along with IV placebo.
Active IN	Ketamine (1st phase)	Will receive IN Ketamine, along with IV placebo.
Active IV	Placebo	Will receive IV Ketamine, along with IN placebo.
Active IV	Ketamine (2st phase)	Will receive IV Ketamine, along with IN placebo.

Primary Outcome Measures

Name	Time	Method
MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline	15 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shalvata MHC; 🇮🇱 Hod Hasharon, Israel