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.

Topic Schizophrenia Depression Bipolar Disorder
Compound Ketamine
Country United Kingdom Israel
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