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Antipsychotic medication is an effective treatment for psychosis. After remission, maintenance treatment significantly reduces relapse rates. Therefore, guidelines recommend maintenance treatment for at least 1 year. Yet, patients have a strong preference to discontinue medication earlier. In addition, one study showed that long-term recovery was better with early disconintuation. We therefore aim to conduct a trial to test if (short and long-term) recovery is better in patients with a first psychotic episode if:

A: medication is continued for at least 1 year after remission (treatment as usual).

B: medication is gradually reduced after 3-6 months in remission

This trial is powered to detect an effect of at least d=0.33 (minimal effect deemed clinically relevant), with an intra-class correlation coefficient of 0.10., alpha=0.05 and a power of 0.80. This requires at least 256 participants per arm. We include an extra 10% to compensate for drop-out.

22 centres collaborate to include 512 patients in three years.

The trial is single-blind with a follow-up of 4 years.

Primary outcome is social recovery, which was decided upon in a survey among patients from the patient organization Anoiksis. This is quantified using the World Health Organization’s Disability Assessment Schedule. Secondary outcomes are: subjective well-being, quality of life, symptom severity, cognition, side effects, somatic health, psychiatric treatments, self-harm and aggressive incidents. Ecological momentary assessments of affect, sleep, social company and activities are assessed via a diary app, as they may provide an early warning sign of psychotic relapse.

Secondary aims are to conduct a cost-effectiveness analysis, a cost-utility analysis and prognostic modeling to identify patient characteristics and treatment specifics to predict good outcome. We will investigate optimal implementation of the best treatment already during the trial using results from two independent interim-analyses.

 

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