Background: Risperidone, a 5-HT2 and D, antagonist, has been shown to
be an effective antipsychotic in the treatment of schizophrenia but ha
s unclear efficacy in the treatment of psychotic affective disorders.
The purpose of the study was to assess the efficacy of risperidone in
the treatment of acute mania with psychotic features. Method: We condu
cted an open-label pilot study of risperidone and concurrent mood-stab
ilizing drugs in the treatment of acute mania with psychotic features.
Patients were diagnosed with the Structured Clinical Interview for DS
M-III-R (SCID). Efficacy was measured weekly with the use of the Young
Mania Rating Scale (YMRS) and the Brief Psychiatric Rating Scale (BPR
S). Results: Ten women and 5 men (mean age = 38 years) were included i
n the study. Of the 13 patients who completed 2 weeks of treatment, 8
of these 13 had a 50% improvement of the BPRS, and all 13 had at least
a 25% improvement (p = .002, 95% confidence interval [CI] = 46.0 to 5
7.8). Of the 8 patients who completed 6 weeks of treatment, 7 of the 8
had a 50% improvement, and all 8 had a 25% improvement (p = .012, 95%
CI = 52.4 to 69.3). Similar results were obtained with the YMRS. By t
he second week of treatment, 10 of the 13 patients remaining in treatm
ent had at least a 50% improvement, and 12 of these 13 had a 25% impro
vement (p = .002, 95% CI = 55.1 to 89.9). By the sixth week, all of th
e 8 patients remaining in treatment had a 75% improvement (p = .012, 9
5% CI = 90.5 to 102.8). The medication was well tolerated, and no case
worsened. Conclusion: When used with concomitant mood-stabilizing dru
gs, risperidone may be effective and well tolerated in patients with a
cute mania with psychotic features. Considering the open design, small
sample size, and limited period of observation, further studies need
to be conducted.