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

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.

Conditions

• Schizophrenia and Related Disorders
• Major Depressive Disorder
• Bipolar Depression

Interventions

DRUG

Clozapine

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DRUG

Esketamine Nasal Product

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DRUG

Escitalopram

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DRUG

Sertraline

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DRUG

Venlafaxine

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DRUG

Lithium

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DRUG

Valproate acid

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DRUG

Quetiapine

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DRUG

Second-line Antidepressants

See arm description

DRUG

Second-line Antipsychotics

See arm description

DRUG

Ketamine Hydrochloride

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DRUG

Esketamine hydrochloride

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DRUG

Bupropion

See arm description

Sponsors & Collaborators

• Universität Münster

  collaborator OTHER

• Dr. Inge Winter

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-27

Primary Completion

2028-06-30

Completion

2028-06-30

Countries

• Israel

Study Locations