Randomised controlled trial of gradual antipsychotic reduction and discontinuation in people with schizophrenia and related disorders: the RADAR trial (Research into Antipsychotic Discontinuation and Reduction)
| Autor: | Sonia Johnson, Rob Horne, Rachael Hunter, Louise Marston, Thomas R. E. Barnes, Joanna Moncrieff, Stefan Priebe, Glyn Lewis, Katherine Darton, Ruth E. Cooper, Nicola Morant, Nadia Crellin, Ruth Smith, Vanessa Pinfold, Lyn J Kent, Nick Freemantle |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Pediatrics medicine.medical_specialty Psychosis Adolescent medicine.medical_treatment BF Drug Administration Schedule law.invention Maintenance Chemotherapy 03 medical and health sciences Young Adult 0302 clinical medicine Quality of life Randomized controlled trial Clinical Protocols law Recurrence medicine Humans Single-Blind Method 030212 general & internal medicine Antipsychotic Adverse effect Aged Aged 80 and over Positive and Negative Syndrome Scale business.industry Correction General Medicine Middle Aged medicine.disease Discontinuation Treatment Outcome Withholding Treatment Schizophrenia Quality of Life Female business 030217 neurology & neurosurgery Antipsychotic Agents Follow-Up Studies |
| Zdroj: | BMJ Open |
| Popis: | IntroductionAntipsychotic medication is effective in reducing acute symptoms of psychosis, but it has a range of potentially serious and debilitating adverse effects and is often disliked by patients. It is therefore essential it is only used when benefits outweigh harms. Although multiple trials conducted with people with schizophrenia indicate an increased risk of relapse in the short-term following abrupt antipsychotic discontinuation, there is little evidence about the long-term outcome of a gradual process of reduction and discontinuation on social functioning, relapse and other outcomes.Methods and analysisThis is a multicentre, randomised controlled trial involving people with schizophrenia and related disorders who have had more than one episode. Participants are randomised to have a clinically-supervised, gradual reduction of antipsychotic medication, leading to discontinuation when possible, or to continue with maintenance treatment. Blinded follow-up assessments are conducted at 6, 12 and 24 months and the primary outcome is social functioning, measured by the Social Functioning Scale at 24 months. A minimum of 134 evaluable participants provides 90% power to detect a five-point difference, and 206 to detect a four-point difference. Secondary outcomes include severe relapse (admission to hospital) and the study is also intended to detect a minimum 10% difference in severe relapse, which requires 402 participants, assuming a 15% loss to follow-up. Other secondary outcomes include all relapses, as identified by an independent and blinded endpoint committee, symptoms measured by the Positive and Negative Syndrome Scale, quality of life, adverse effects, self-rated recovery and neuropsychological measures. Enrolment started in 2016. The trial is scheduled to finish in June 2022.Ethics and disseminationEthical approval was initially obtained on 27 October 2016 (UK Research Ethics Committee reference 16/LO/1507). Results will be published in peer-reviewed journals and disseminated to the public.Trial registration numberISRCTN90298520. EudraCT: 2016-000709-36. Pre-results. |
| Databáze: | OpenAIRE |
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