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The clinical effectiveness and cost effectiveness of clozapine for inpatients with severe borderline personality disorder (CALMED study): a randomised placebo-controlled trial.
Crawford, Mike J; Leeson, Verity C; Evans, Rachel; Barrett, Barbara; McQuaid, Aisling; Cheshire, Jack; Sanatinia, Rahil; Lamph, Gary; Sen, Piyal; Anagnostakis, Katina; Millard, Louise; Qurashi, Inti; Larkin, Fintan; Husain, Nusrat; Moran, Paul; Barnes, Thomas R E; Paton, Carol; Hoare, Zoe; Picchioni, Marco; Gibbon, Simon.
  • Crawford MJ; Division of Psychiatry, Imperial College London, The Commonwealth Building, The Hammersmith Hospital, Du Cane Road, London W12 0NN, UK.
  • Leeson VC; Division of Psychiatry, Imperial College London, London, UK.
  • Evans R; North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.
  • Barrett B; King's Health Economics, King's College London, London, UK.
  • McQuaid A; Division of Psychiatry, Imperial College London, London, UK.
  • Cheshire J; Department of Forensic Psychiatry, Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK.
  • Sanatinia R; Division of Psychiatry, Imperial College London, London, UK.
  • Lamph G; School of Nursing, University of Central Lancashire, Preston, UK.
  • Sen P; Department of Forensic Psychiatry, Elysium Healthcare, Milton Keynes, UK.
  • Anagnostakis K; St Andrew's Academic Centre, St Andrew's Healthcare, Northampton, UK.
  • Millard L; St Andrew's Academic Centre, St Andrew's Healthcare, Northampton, UK.
  • Qurashi I; Ashworth Hospital, Mersey Care NHS Foundation Trust, Liverpool, UK.
  • Larkin F; Acute Mental Health Services, West London NHS Trust, London, UK.
  • Husain N; Division of Psychology & Mental Health, University of Manchester, Manchester, UK.
  • Moran P; Centre for Academic Mental Health, University of Bristol, Bristol, UK.
  • Barnes TRE; Division of Psychiatry, Imperial College London, London, UK.
  • Paton C; Division of Psychiatry, Imperial College London, London, UK.
  • Hoare Z; North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.
  • Picchioni M; Department of Forensic and Neurodevelopmental Science, Kings College London, London, UK.
  • Gibbon S; Department of Forensic Psychiatry, Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK.
Ther Adv Psychopharmacol ; 12: 20451253221090832, 2022.
Article in English | MEDLINE | ID: covidwho-1822143
ABSTRACT

Background:

Data from case series suggest that clozapine may benefit inpatients with borderline personality disorder (BPD), but randomised trials have not been conducted.

Methods:

Multicentre, double-blind, placebo-controlled trial. We aimed to recruit 222 inpatients with severe BPD aged 18 or over, who had failed to respond to other antipsychotic medications. We randomly allocated participants on a 11 ratio to receive up to 400 mg of clozapine per day or an inert placebo using a remote web-based randomisation service. The primary outcome was total score on the Zanarini Rating scale for Borderline Personality Disorder (ZAN-BPD) at 6 months. Secondary outcomes included self-harm, aggression, resource use and costs, side effects and adverse events. We used a modified intention to treat analysis (mITT) restricted to those who took one or more dose of trial medication, using a general linear model fitted at 6 months adjusted for baseline score, allocation group and site.

Results:

The study closed early due to poor recruitment and the impact of the COVID-19 pandemic. Of 29 study participants, 24 (83%) were followed up at 6 months, of whom 21 (72%) were included in the mITT analysis. At 6 months, 11 (73%) participants assigned to clozapine and 6 (43%) of those assigned to placebo were still taking trial medication. Adjusted difference in mean total ZAN-BPD score at 6 months was -3.86 (95% Confidence Intervals = -10.04 to 2.32). There were 14 serious adverse events; 6 in the clozapine arm and 8 in the placebo arm of the trial. There was little difference in the cost of care between groups.

Interpretation:

We recruited insufficient participants to test the primary hypothesis. The study findings highlight problems in conducting placebo-controlled trials of clozapine and in using clozapine for people with BPD, outside specialist inpatient mental health units. Trial registration ISRCTN18352058. https//doi.org/10.1186/ISRCTN18352058.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: Ther Adv Psychopharmacol Year: 2022 Document Type: Article Affiliation country: 20451253221090832

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: Ther Adv Psychopharmacol Year: 2022 Document Type: Article Affiliation country: 20451253221090832