Efficacy, safety and tolerability of two dosing regimens in adolescent schizophrenia: double-blind study.
BACKGROUND
Effective treatments for adolescent schizophrenia are needed.


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


METHODS
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).


BACKGROUND
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.
Haas
Magali
M
Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica NV, Beerse, Belgium. mhaas8@its.jnj.com
Eerdekens
Mariëlle
M
Kushner
Stuart
S
Singer
Julia
J
Augustyns
Ilse
I
Quiroz
Jorge
J
Pandina
Gahan
G
Kusumakar
Vivek
V
D000208:Acute Disease; D000293:Adolescent; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D011388:Prolactin / Q000187:drug effects; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D018967:Risperidone / Q000008:administration & dosage* / Q000009:adverse effects; D012559:Schizophrenia / Q000188:drug therapy*; D015430:Weight Gain
D014150:Antipsychotic Agents; D011388:Prolactin; D018967:Risperidone