Clinical TrialTreatment-Resistant Depression (TRD)EsketamineKetamineCompleted

Intranasal Esketamine to Maintain the Antidepressant Response to IV Racemic Ketamine

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.

Target Enrollment
10 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

Retrospective case series of 10 consecutive outpatients with treatment-resistant depression who responded to an induction course of IV racemic ketamine and were switched to intranasal esketamine for maintenance.

IV ketamine was given at 0.5 mg/kg with flexible dosing up to 1.0 mg/kg (series of six infusions over 14–21 days). IN esketamine was started at 28 mg or 56 mg and titrated to 84 mg; outcomes included MADRS, PHQ‑9, CGI‑I, vital signs and adverse events, with REMS monitoring for IN esketamine.

Study Protocol

Preparation

sessions

Dosing

6 sessions

Integration

sessions

Study Arms & Interventions

IN esketamine maintenance

experimental

Outpatients with TRD who responded to IV racemic ketamine switched to intranasal esketamine for maintenance; concomitant psychotropic medications continued.

Interventions

  • Esketamine84 mg
    via Other• maintenance (variable)

    Initial 28 mg (n=1) or 56 mg (n=9) then titrated to target 84 mg for remainder of treatments; monitored under REMS.

  • Ketamine0.5 - 1 mg/kg
    via IV• induction series then flexible maintenance• 6 doses total

    Subanaesthetic IV racemic ketamine induction (0.5 mg/kg, titrated to 1.0 mg/kg); series of six infusions over 14–21 days, then weekly x4 if response, then variable maintenance.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Diagnosis of major depression, recurrent, severe without psychotic symptoms according to DSM-5; must be diagnosed with Treatment Resistant Depression.
  • 18 years and up. Patients had a clinically meaningful response to a course of IV racemic ketamine.

Exclusion Criteria

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

Study Details

Locations

PsychAtlanta — Marietta, Georgia, United States

Your Library