The British Journal of Psychiatry (2009) 194: 158-164. doi: 10.1192/bjp.bp.107.046177
© 2009 The Royal College of Psychiatrists
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Efficacy, safety and tolerability of two risperidone dosing regimens in adolescent schizophrenia: double-blind study

Magali Haas, MD, PhD and Mariëlle Eerdekens, MD, MBA

Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica NV, Beerse, Belgium

Stuart Kushner, MD and Julia Singer, PhD

Johnson & Johnson Pharmaceutical Research & Development, LLC, New Jersey, USA

Ilse Augustyns, PhD

Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica NV, Beerse, Belgium

Jorge Quiroz, MD, Gahan Pandina, PhD and Vivek Kusumakar, MD, FRCPC

Johnson & Johnson Pharmaceutical Research & Development, LLC, New Jersey, USA

Correspondence: Dr Magali Haas, Turnhoutseweg 30, 2340 Beerse, Belgium. Email: mhaas8{at}its.jnj.com

Declaration of interest

Funded by Johnson & Johnson Pharmaceutical Research & Development, LLC. M.H. and M.E. are employees of Johnson & Johnson Research & Development, Division of Janssen Pharmaceutica, NV, S.K., J.S., I.A., J.Q., G.P. and V.K. are employees of Johnson & Johnson Pharmaceutical Research & Development, LLC.

Background

Effective treatments for adolescent schizophrenia are needed.

Aims

To compare efficacy and safety of two dosing regimens of risperidone.

Method

Double-blind, 8-week study. Patients, 13–17 years, with an acute episode of schizophrenia, randomised 1:1 to risperidone 1.5–6.0 mg/day (regimen A; n=125) or 0.15–0.6 mg/day (regimen B; n=132). Trial registration number: NCT00034749.

Results

Mean total Positive and Negative Syndrome Scale (PANSS) score improved significantly (P<0.001; effect size=0.49) from baseline to end-point for regimen A (mean=96.4 (s.d.=15.39) to mean=72.8 (s.d.=22.52)) compared with regimen B (mean=93.3 (s.d.=14.14) to mean=80.8 (s.d.=24.33)). Treatment-emergent adverse events occurred in 74% (regimen A) and 65% (regimen B) of patients; 4% of patients overall discontinued for adverse events. Mean change in body weight was 3.2 kg (s.d.=3.49) for regimen A and 1.7 kg (s.d.=3.29) for regimen B.

Conclusions

Adolescent patients in the regimen A group showed greater improvement in total PANSS compared with the regimen B group. Treatment was well tolerated.




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A. K. Jainer and A. Mahmood
Risperidone for adolescent schizophrenia
The British Journal of Psychiatry, June 1, 2009; 194(6): 568 - 569.
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Re: Risperidone for adolescent schizophrenia: double blind study
Ashok Kumar Jainer, et al.
BJP Online, 19 Mar 2009 [Full text]
Re: Re: Risperidone for adolescent schizophrenia: double blind study
Magali Haas, et al.
BJP Online, 30 Mar 2009 [Full text]