ROQUEL XR is not approved for patients under the age of 18 years. In a short-term placebo-controlled monotherapy trial in adolescent patients with schizophrenia (6-week duration), the aggregated incidence of extrapyramidal symptoms was 12.9% for SEROQUEL and 5.3% for placebo, though the incidence of the individual adverse events (eg, akathisia, tremor, extrapyramidal disorder, hypokinesia, restlessness, psychomotor hyperactivity, muscle rigidity, dyskinesia) did not exceed 4.1% in any treatment group. In a short-term placebo-controlled monotherapy trial in children and adolescent patients with bipolar mania (3-week duration), the aggregated incidence of extrapyramidal symptoms was 3.6% for SEROQUEL and 1.1% for placebo.
Table 18 below presents a listing of patients with Adverse Experiences potentially associated with EPS in the short-term placebo-controlled monotherapy trial in adolescent patients with schizophrenia (6-week duration).
Table 18 Adverse experiences potentially associated with EPS in the short-term placebo-controlled monotherapy trial in adolescent patients with schizophrenia (6-week duration). *
: Patients with the following terms were counted in this category: nuchal rigidity, hypertonia, dystonia, muscle rigidity
†
: Patients with the following terms were counted in this category: cogwheel rigidity, tremor
‡
: Patients with the following terms were counted in this category: akathisia
§
: Patients with the following terms were counted in this category: tardive dyskinesia, dyskinesia, choreoathetosis
¶
: Patients with the following terms were counted in this category: restlessness; extrapyramidal disorder
Preferred term
Placebo
(N=75)
Quetiapine 400 mg/day
(N=73)
Quetiapine 800 mg/day
(N=74)
All Quetiapine
(N=147)
n
%
n
%
n
%
n
%
Dystonic event*
0
0.0
2
2.7
0
0.0
2
1.4
Parkinsonism†
2
2.7
4
5.5
4
5.4
8
5.4
Akathisia‡
3
4.0
3
4.1
4
5.4
7
4.8
Dyskinetic event§
0
0.0
2
2.7
0
0.0
2
1.4
Other extrapyramidal event¶
0
0.0
2
2.7
2
2.7
4
2.7
Table 19 below presents a listing of patients with Adverse Experiences potentially associated with EPS in a short-term placebo-controlled monotherapy trial in children and adolescent patients with bipolar mania (3-week duration)
Table 19: Adverse experiences potentially associated with EPS in a short-term placebo-controlled monotherapy trial in children and adolescent patients with bipolar mania (3-week duration) *
: There were no adverse experiences with the preferred term of dystonic or dyskinetic events.
†
: Patients with the following terms were counted in this category: cogwheel rigidity, tremor
‡
: Patients with the following terms were counted in this category: akathisia
§
: Patients with the foll
