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NCT05603104 · ClinicalTrials.gov record · last posted 2026-01-22

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

Study acronym: INTENSIFY
StatusRecruiting
PhasePhase 3
Started2025-04-27
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 17 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 17 times since 2022-10-27; most recent amendment 2026-01-19. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-07-22
Status change Not Yet RecruitingRecruitingv10
Trial Details
NCT Number NCT05603104
Lead Sponsor Dr. Inge Winter
Collaborators: Universität Münster
Conditions Schizophrenia and Related Disorders, Major Depressive Disorder, Bipolar Depression
Enrollment 1,254 participants
Start Date 2025-04-27
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-22