Abstract
BackgroundThe aim of the TAILOR trial is to investigate the effect of closely monitored tapering/discontinuation versus maintenance therapy with antipsychotic medication in patients with newly diagnosed schizophrenia or persistent delusional disorder and with minimum 3 months’ remission of psychotic symptoms.Methods and designTwo hundred and fifty patients will be included from the psychiatric early intervention program, OPUS, in two regions in Denmark. Inclusion criteria are: ICD-10 diagnoses schizophrenia (F20, except F20.6) or persistent delusional disorder (F22), minimum 3 months’ remission of psychotic symptoms and in treatment with antipsychotic medication (except clozapine). The patients will be randomized to maintenance therapy or tapering/discontinuation with antipsychotic medication in a 1-year intervention. The tapering/discontinuation group will be using a smartphone application to monitor early warning signs of psychotic relapse. Patients will be assessed at baseline, 1-, 2- and 5-year follow-up regarding psychotic and negative symptoms, side-effects of antipsychotic medication, social functioning, cognitive functioning, perceived health status, patient satisfaction, substance and alcohol use, sexual functioning and quality of life. The primary outcome will be remission of psychotic symptoms and no antipsychotic medication after 1 year. Secondary outcome measures will include: co-occurrence of remission of psychotic symptoms and 0–1-mg haloperidol equivalents of antipsychotic medication after 1-year intervention; antipsychotic dose; antipsychotic side effects; negative symptoms; social functioning; cognitive functioning; and patient satisfaction. Exploratory outcomes will include remission, clinical recovery, substance and alcohol use, sexual functioning, quality of life, self-beliefs of coping and user experience of support from health workers. Safety measures will include death, admissions to psychiatric hospital, severe self-harm and psychotic relapses.DiscussionThe TAILOR trial will contribute knowledge about the effect of tapering/discontinuation of antipsychotic medication in the early phases of schizophrenia and related disorders and the results may guide future clinical treatment regimens of antipsychotic treatment.Trial registrationEU Clinical Trials Register – EudraCT number: 2016-000565-23. Registered on 5 February 2016.
Highlights
The aim of the TAILOR trial is to investigate the effect of closely monitored tapering/discontinuation versus maintenance therapy with antipsychotic medication in patients with newly diagnosed schizophrenia or persistent delusional disorder and with minimum 3 months’ remission of psychotic symptoms
In the TAILOR trial only the researchers are blinded, neither clinicians nor patients, because they should be attentive of the high risk of relapse in the discontinuation group
The TAILOR trial only includes assessor blinding and the interventions might end up being more similar than intended and there is a risk that the patient and physician will misinterpret warnings signs or side effects
Summary
This paper was written in line with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 explanation and elaboration: guidance for protocols of clinical trials [27] and the SPIRIT Checklist and flow chart were used, see Additional file 1 and Fig. 1. This group is comparable to the expected number for our control group (see Table 1) Based on this number, the sample size calculation was performed with alpha = 0.05 and 80% power to detect the minimum relevant difference if the tapering/discontinuation group at 1-year follow-up has an event rate of 39.7% on remission without antipsychotic medication (see Table 1). The sample size calculation was performed with alpha = 0.05 and 80% power to detect the minimum relevant difference if the tapering/discontinuation group at 1-year follow-up has an event rate of 39.7% on remission without antipsychotic medication (see Table 1) This yields a required sample size of 125 patients in each group, i.e., a total of 250 patients in the TAILOR trial. The clinicians will not have access to data collected from assessments done by the researchers
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