Clinical trial NCT05958875: The Effect of a Six Week Intensified Pharmacological Treatment for Schizophrenia Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
Official title: A Randomised, Controlled Trial to Investigate the Effect of a Six Week Intensified Pharmacological Treatment for Schizophrenia Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
Conditions: Schizophrenia and Related Disorders
Early Treatment-Resistance
Summary: Schizophrenia (SZ) affects approximately 4.5 million people across the European Union (EU) and is associated with annual healthcare and societal costs of 29 billion Euros. The impact on the daily life of patients is huge, ranging from frequent relapses and hospitalisations, the inability to maintain a job or continue scholing, to a low quality of life, impaired cognitive functioning, suicidal ideation and an increase morbidity rate, next to the large burden for carers 1. When diagnosed with schizophrenia or related disorder, patients are commonly prescribed antipsychotics. One-third of the schizophrenia patients are regarded treatment-resistant (TR), meaning that at least two antipsychotic trials have failed. Typically, clozapine is prescribed for TR patients, which is effective for approximately 40% of patients. Clozapine is among the most effective treatments, with the lowest all-cause mortality. Although it is among the most effective antipsychotics, it is generally not used earlier in the illness course due to a small risk of severe neutropenia/agranulocytosis, which is why patients treated with clozapine are intensely monitored. However, this small risk outweighs the burden of not receiving an effective treatment.
Since clozapine is among the most effective treatments, this leads to the research question whether earlier initiation of third-line treatment ('early intensified' pharmacological treatment; EIPT) would be more beneficial than the current second-line treatments (treatment as usual; TAU). If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments, hospitalisations, and recommendations for adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs The INTENSIFY-Schizophrenia trial is part of the larger Horizon 2021 project Psych-STRATA, with the central goal of paving the way for a shift towards a treatment decision-making process tailored for the individual at risk for treatment resistance. To that end, the inestigators aim to establish evidence-based criteria to make decisions of early intense treatment in individuals at risk for treatment resistance across the major psychiatric disorders of schizophrenia, bipolar disorder and major depression. The current protocol focuses on the sample of schizophrenia patients.
Interventions:
description: Participants are randomized to clozapine or second-line antipsychotics. When randomised to clozapine, they will receive clozapine for six weeks.
name: Clozapine
other_name: ATC code: N05AH02
type: Drug
description: Participants are randomized to clozapine or second-line antipsychotics. When randomized to second-line antipsychotics, this means participants will receive treatment as usual. The physician has the choice to administer any second-line antipsychotic. More specification is not possible, as this is a choice the physician makes with the participant based on the characteristic and preference of the participant (in line with standard clinical practice).
name: Second-line Antipsychotics (treatment as usual)
type: Drug
Study arms:
design_group_description: Subject with schizophrenia, randomized to EIPT: Switch to clozapine. Brand, dosage, frequency and duration up to the investigator's discretion
design_group_title: Schizophrenia early intensified treatment (EIPT): Switch to clozapine
design_group_type: Experimental
design_group_description: Subject with schizophrenia or related disorder randomized to TAU: switch to second-line antispychotic. Compound, brand, dosage, frequency and duration up to the investigator's discretion (in accordance with SmPC)
design_group_title: Schizophrenia treatment as usual (TAU): second-line antispychotic
design_group_type: Active Comparator
Sponsor: University Medical Center of Utrecht
Collaborators: Universität Leipzig
Drug name mappings:
name: 氯氮平
lang: CN
name: Clozapine
lang: EN
name: クロザピン
lang: JP