Acute and continuation risperidone monotherapy in mania.
BACKGROUND
The aim of this study was to assess the effectiveness and safety of risperidone monotherapy for acute and continuation treatment of mania.


METHODS
Ninety-six DSM-IV acutely manic bipolar patients with a Young mania rating score (YMRS) of 20 or more entered this open, multicentre, 6-month study. Efficacy was assessed with the YMRS, the positive and negative syndrome scale (PANSS) and the clinical global impressions scale (CGI). Safety was assessed with the UKU side effect rating scale and with the Hamilton depression rating scale, for the assessment of a switch to depression.


RESULTS
80 patients (83.3%) completed the study. Using the last-observation-carried-forward analysis, risperidone produced highly significant improvements (p<0.0001) on the all efficacy measures from weeks 1 (YMRS) and 4 (PANSS and CGI) onwards, for a 6-month period. There was a significant increase in extrapyramidal side-effects by week 4 (p=0.015) and a significant decrease at the 6-month endpoint (p=0.027). Risperidone did not induce depressive symptoms, as mean HDRS scores actually improved (p<0.0001), and exacerbation of mania was rare (n=4, 4.2%). The mean dose of risperidone was 4.2 mg/day.


CONCLUSIONS
Monotherapy with risperidone is effective and well tolerated in acute and continuation treatment of mania. The results should be confirmed in randomized, double-blind clinical trials.
Vieta
Eduard
E
Bipolar Disorders Programme, Clinical Institute of Psychiatry and Psychology, Hospital Clinic, University of Barcelona, IDIBAPS, Spain. evieta@clinic.ub.es
Brugué
Esteve
E
Goikolea
José Manuel
JM
Sánchez-Moreno
Jose
J
Reinares
María
M
Comes
Mercè
M
Colom
Francesc
F
Martínez-Arán
Anabel
A
Benabarre
Antoni
A
Torrent
Carla
C
D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D018967:Risperidone