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

This randomized, controlled trial (n=1254) investigates the effect of an intensified pharmacological treatment (including ketamine) for schizophrenia, major depressive disorder (MDD), and bipolar depression in subjects who experienced a first-time treatment failure on their first-line treatment.

Led by Dr. Inge Winter and collaborators, the study aims to compare the treatment response under an early-intensified pharmacological treatment to that under treatment as usual. Participants aged 18 to 70 diagnosed with schizophrenia, MDD, or bipolar depression are eligible.

The trial involves six arms, each focusing on a specific disorder, with treatments including switching to clozapine for schizophrenia, esketamine nasal spray for MDD, and combinations of antidepressants and mood stabilizers for bipolar depression.

The primary outcome measures include changes in symptom severity assessed using various scales specific to each disorder. The trial duration is 4-6 weeks, with assessments conducted at baseline and end of treatment.

The study is planned internationally, with sites in the UK and Israel. Recruitment is not yet started, and the study is expected to continue until October 2024.

Trial Details

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) would be more efficacious than the current second-line treatments (treatment as usual) 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.

NCT Number NCT05603104

Data attribution

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