RecruitingPhase 3NCT05603104

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

A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.


Sponsor

Dr. Inge Winter

Enrollment

1,254 participants

Start Date

Apr 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a more intensive, personalized pharmacological (medication-based) treatment approach leads to better outcomes for people with schizophrenia, major depressive disorder (MDD), or bipolar depression who did not respond to their first medication treatment. It compares different medication strategies after the first treatment has failed. **You may be eligible if...** - You are 18 or older (upper age limits vary: up to 70 for schizophrenia, 65 for depression) - You have a diagnosis of schizophrenia, major depressive disorder, or bipolar depression - You did not respond well to your first medication treatment for this condition - You are willing and able to give written informed consent **You may NOT be eligible if...** - You have serious medical conditions that conflict with the study medications - You are currently pregnant or not using adequate contraception (for women of childbearing age) - You have active substance dependency that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClozapine

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DRUGEsketamine Nasal Product

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DRUGEscitalopram

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DRUGSertraline

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DRUGVenlafaxine

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DRUGLithium

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DRUGValproate acid

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DRUGQuetiapine

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DRUGSecond-line Antidepressants

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DRUGSecond-line Antipsychotics

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DRUGKetamine Hydrochloride

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DRUGEsketamine hydrochloride

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DRUGBupropion

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Locations(1)

Sheba Medical Center

Ramat Gan, Israel

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NCT05603104


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