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

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 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
• Actual Primary Completion Date: May 2020
• Actual Study Completion Date: May 2020

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Israel

Shalvata MHC

Hod Hasharon, Israel, POB 94

Sponsors and Collaborators

Shalvata Mental Health Center

Investigators

• Principal Investigator: Aviv Segev, MD; Shalvata MHC

More Information

• Responsible Party: Aviv Segev, Head, Psychiatric Emergency Services, Shalvata Mental Health Center
• ClinicalTrials.gov Identifier: NCT02644629
• Other Study ID Numbers: SHA-15-0019
• First Posted: January 1, 2016
• Last Update Posted: October 28, 2020
• Last Verified: October 2020

Additional relevant MeSH terms:

Depressive Disorder; Depressive Disorder, Major; Mood Disorders; Mental Disorders; 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