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A National Quality Improvement Collaborative for the clinical use of outcome measurement in specialised mental healthcare: Results from a parallel group design and a nested cluster randomised controlled trial
Metz,M.J. Verbeek,M.A. Franx,G.C. van der Feltz-Cornelis,C.M. de Beurs,E. Beekman,A.T.F.
Metz,M.J.
Verbeek,M.A.
Franx,G.C.
van der Feltz-Cornelis,C.M.
de Beurs,E.
Beekman,A.T.F.
Abstract
Background: Hyperprolactinaemia is a troublesome side-effect of treatment with antipsychotics. Aims This double-blind, placebo-controlled study aimed at examining the effect of adjunctive treatment with 10 mg aripiprazole on prolactin levels and sexual side-effects in patients with schizophrenia symptomatically maintained on risperidone. Method: Thirty patients taking risperidone were enrolled into the trial (CTRI/2012/11/003114). Aripiprazole was administered at a fixed daily dose of 10 mg/day for 8 weeks. Serum prolactin was measured at baseline and at 8 weeks. Hyperprolactinaemia-related problems, psychopathology and side-effects were evaluated every 2 weeks. Results: Prolactin levels decreased by 58% in the aripiprazole group compared with an increase by 22% in the placebo group. Prolactin levels normalised in 46% of patients in the aripiprazole group (number needed to treat, NNT=2). Aripiprazole improved erectile dysfunction in five out of six patients. There were no significant differences in change in psychopathology or side-effects between groups. Conclusions: Adjunctive aripiprazole reduced prolactin levels in those treated with risperidone, with no effect on psychopathology and extrapyramidal symptoms. This is a potential treatment for hyperprolactinaemia observed during treatment with second-generation antipsychotics.
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2017
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Metz, M J, Verbeek, M A, Franx, G C, van der Feltz-Cornelis, C M, de Beurs, E & Beekman, A T F 2017, 'A National Quality Improvement Collaborative for the clinical use of outcome measurement in specialised mental healthcare : Results from a parallel group design and a nested cluster randomised controlled trial', BJPsych Open, vol. 3, no. 3, pp. 106-112. https://doi.org/10.1192/bjpo.bp.116.004366