A Stratified Treatment Algorithm in Psychiatry: A program on stratified pharmacogenomics in severe mental illness

 / Psych-STRATA’s INTENSIFY Trials Enroll First Participants: Expanding Mental Health Treatment Research

Psych-STRATA’s INTENSIFY Trials Enroll First Participants: Expanding Mental Health Treatment Research

We are excited to announce significant progress within Psych-STRATA Work Package 3 (WP3) as the INTENSIFY trials have successfully enrolled their first participants for the schizophrenia and major depressive disorder studies. These trials aim to evaluate whether third-line treatments can provide better outcomes compared to second-line treatments for patients requiring more advanced therapeutic interventions.

Patient Enrolment Underway
At present, clinical trial sites in Münster and Bielefeld (Germany), are enrolling patients, while sites in Innsbruck (Austria), Ramat Gan (Israel), and Barcelona (Spain), are actively screening to find additional eligible participants for the trials. In the coming months, more sites across Europe will open their doors, with further enrolment expected to begin in Autumn 2024. Notably, we are eagerly anticipating the first participant enrolment for the INTENSIFY bipolar disorder trial.

Wider Expansion Planned
With unconditional approval to begin studies at all EU sites and Israel, the trials are on track to expand further. A new site in Athens (Greece) has also been onboarded, with documentation submitted to authorities. We expect the Athens site to begin screening participants by early 2025. Additionally, the UK site for the INTENSIFY schizophrenia study has received its unconditional approval, further broadening the scope of the trials.

Supporting Recruitment Efforts
To boost patient recruitment, the Psych-STRATA team will introduce an enrolment package during the General Assembly in Bologna on 25 September 2024. This package will include tips, tools, and strategies to enhance recruitment efforts at each clinical site, ensuring that eligible participants are efficiently identified and enrolled in the trials.

The INTENSIFY trials mark a crucial step in advancing personalised treatment options for mental health conditions, with the potential to offer improved outcomes for those affected by schizophrenia, major depressive disorder, and bipolar disorder. We are committed to pushing the boundaries of mental health treatment research and look forward to continued success as the trials progress.

Stay tuned for further updates as we expand the INTENSIFY trials and work to improve mental health care for all!