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

Brief 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.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym

INTENSIFY

status

RECRUITING

phase

PHASE3

study type

INTERVENTIONAL

enrollment

1254

sponsor

Dr. Inge Winter

conditions

Schizophrenia and Related Disorders; Major Depressive Disorder; Bipolar Depression

interventions

DRUG: Clozapine; DRUG: Esketamine Nasal Product; DRUG: Escitalopram; DRUG: Sertraline; DRUG: Venlafaxine; DRUG: Lithium; DRUG: Valproate acid; DRUG: Quetiapine; DRUG: Second-line Antidepressants; DRUG: Second-line Antipsychotics

start date

2025-04-27

start date type

ACTUAL

primary completion date

2028-06-30

has results

false

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters