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

M.J. Metz, M.A. Verbeek, G.C. Franx, C.M. van der Feltz-Cornelis, E. de Beurs, A.T.F. Beekman

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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.
Original languageEnglish
Pages (from-to)106-112
JournalBritish Journal of Psychiatry Open
Volume3
Issue number3
DOIs
Publication statusPublished - 2017

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Delivery of Health Care
Hyperprolactinemia
Risperidone
Placebos
Aripiprazole
Serum

Cite this

@article{95efa8cee38544a8a0f026e4718b3274,
title = "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",
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.",
author = "M.J. Metz and M.A. Verbeek and G.C. Franx and {van der Feltz-Cornelis}, C.M. and {de Beurs}, E. and A.T.F. Beekman",
year = "2017",
doi = "10.1192/bjpo.bp.116.004366",
language = "English",
volume = "3",
pages = "106--112",
journal = "British Journal of Psychiatry Open",
issn = "2056-4724",
publisher = "Cambridge University Press",
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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.

In: British Journal of Psychiatry Open, Vol. 3, No. 3, 2017, p. 106-112.

Research output: Contribution to journalArticleScientificpeer-review

TY - JOUR

T1 - A National Quality Improvement Collaborative for the clinical use of outcome measurement in specialised mental healthcare

T2 - Results from a parallel group design and a nested cluster randomised controlled trial

AU - Metz, M.J.

AU - Verbeek, M.A.

AU - Franx, G.C.

AU - van der Feltz-Cornelis, C.M.

AU - de Beurs, E.

AU - Beekman, A.T.F.

PY - 2017

Y1 - 2017

N2 - 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.

AB - 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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