drugset / Trial / NCT05603104

Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure

NCT05603104

Phase 3 Recruiting 1254 enrolled Dr. Inge Winter Universität Münster · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early-intensified treatments) when used earlier in the disease course for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.

Timeline

Start
2025-04-27
Primary completion
2028-06-30
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupropion Small molecule
Subject Clozapine Other / unclassified
Subject Escitalopram Small molecule
Subject Esketamine Other / unclassified Intravenous
Subject Esketamine Nasal Product Unknown 28 mg Intranasal
Subject Ketamine Small molecule Intravenous
Subject Lithium Unknown
Subject Quetiapine Small molecule
Subject Sertraline Small molecule
Subject Valproate Small molecule
Subject Venlafaxine Small molecule