Intranasal Esketamine to Maintain the Antidepressant Response to IV Racemic Ketamine

NCT04856124 | Completed FDA Drug

• 1 other identifier: #1262
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the efficacy and safety of intranasal esketamine as maintenance antidepressant therapy in patients who have demonstrated clinical improvement with off-label intravenous racemic ketamine for treatment-resistant depression.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  Depression relapse based on MADRS

  12 months

Secondary Outcomes (2)

• Patient-Health Questionnaire-9 (PHQ-9)

  12 months

• Clinical Global Impression of Improvement scale- CGI-I

  12 months

Study Arms (1)

Treatment resistant depressed outpatients

Subjects had a clinically meaningful response to IV racemic ketamine and remained on other psychotropic medications during treatment with both IV ketamine and IN esketamine. Concomitant medication classes included CNS stimulants (n = 7), atypical antipsychotics (n = 6), selective serotonin reuptake inhibitors (n = 5), serotonin/norepinephrine reuptake inhibitors (n = 4), anticonvulsants (n = 3), antipsychotics (n = 3), mood stabilizers (n = 3), benzodiazepines (n = 2), norepinephrine/dopamine reuptake inhibitors (n = 2), alpha 2 antagonists (n=1), and sedative hypnotics (n = 1). Two patients (20%) previously underwent ECT with partial but transient relief from depressive symptoms, two (20%) failed TMS, and no patients reported any period of greater than 50% improvement during their current depressive episode prior to ketamine treatment.

Drug: Intranasal esketamine

Interventions

Intranasal esketamine DRUG

Subjects with a clinically meaningful response to IV racemic ketamine were switched to IN esketamine

Also known as: IV racemic ketamine

Treatment resistant depressed outpatients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Six females and four males with a mean age of 41.1 years. Nine (90%) had one or more psychiatric diagnoses, including generalized anxiety disorder (n = 9), attention deficit hyperactivity disorder (n = 4), post-traumatic stress disorder (n = 3), and panic disorder (n = 1). Six (60%) were unemployed at baseline due to the disabling effects of their depression and five (50%) reported daily suicidal ideation prior to treatment. The duration of the current depressive episode ranged between 5 and 20 years.

You may qualify if:

• Diagnosis of major depression, recurrent, severe without psychotic symptoms according to criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). Must be diagnosed with Treatment resistant depression.
• years old and up Patients had a clinically meaningful response to a course of IV racemic ketamine

You may not qualify if:

• Active substance abuse, psychosis, significant medical comorbidities, or axis II diagnosis that would interfere with the reliability of outcome measures or response to pharmacotherapy.

Sponsors & Collaborators

• Psych Atlanta: lead

Study Sites (1)

PsychAtlanta

Marietta, Georgia, 30060, United States

Location

Related Publications (1)

• Banov MD, Landrum RE, Moore MB, Szabo ST. Switching to Intranasal Esketamine Maintains the Antidepressant Response to Intravenous Racemic Ketamine Administration: A Case Series of 10 Patients. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):594-599. doi: 10.1097/JCP.0000000000001456.

  PMID: 34411009 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michael Banov MD, DFAPA

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 23, 2021
• Study Start: September 1, 2018
• Primary Completion: December 15, 2020
• Study Completion: March 1, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

US (1)