drugset
drugset / Trial / NCT06278779

Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression

NCT06278779 ↗

Phase 4 Recruiting 162 enrolled The George Institute The University of New South Wales · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are: * How the two formulations compare in terms of their effectiveness in treating TRD. * How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness. Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes.

Timeline

Start
2024-06-03
Primary completion
2027-04
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Esketamine Other / unclassified 28 mg Intranasal
Comparator Esketamine Other / unclassified 56 mg Intranasal
Comparator Esketamine Other / unclassified 84 mg Intranasal
Comparator KETAMINE Small molecule 0.5 mg/kg Other

Indications

No indication recorded.