ical Trial for Bipolar Depression *
: There were no adverse experiences with the preferred term of dyskinetic event.
†
: Patients with the following terms were counted in this category: nuchal rigidity, hypertonia, dystonia, muscle rigidity, oculogyration
‡
: Patients with the following terms were counted in this category: cogwheel rigidity, tremor, drooling, hypokinesia
§
: Patients with the following terms were counted in this category: akathisia, psychomotor agitation
¶
: Patients with the following terms were counted in this category: restlessness; extrapyramidal disorder, movement disorder
Preferred Term*
Placebo (N=140)
SEROQUEL XR (N=137)
n
%
n
%
Dystonic event†
0
0.0
2
1.5
Parkinsonism‡
1
0.7
1
0.7
Akathisia§
0
0.0
2
1.5
Other extrapyramidal event¶
0
0.0
1
0.7
In two placebo-controlled short-term adjunctive therapy clinical trials for the treatment of MDD utilizing between 150 mg and 300 mg of SEROQUEL XR, the incidence of any adverse reactions potentially related to EPS was 5.1% for SEROQUEL XR and 4.2% for the placebo group.
Table 17 shows the percentage of patients experiencing adverse reactions potentially associated with EPS in adjunct clinical trials for MDD by dose:
Table 17: Adverse Reactions Potentially Associated with EPS in MDD Trials by Dose, Adjunctive Therapy Clinical Trials (6 weeks duration) *
: Patients with the following terms were counted in this category: nuchal rigidity, hypertonia, dystonia, muscle rigidity, oculogyration
†
: Patients with the following terms were counted in this category: cogwheel rigidity, tremor, drooling, hypokinesia
‡
: Patients with the following terms were counted in this category: akathisia, psychomotor agitation
§
: 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, movement disorder
Preferred term
Placebo
(N=309)
SEROQUEL XR 150 mg/day
(N=315)
SEROQUEL XR 300 mg/day
(N=312)
All Doses
(N=627)
n
%
n
%
n
%
n
%
Dystonic event*
0
0.0
1
0.3
0
0.0
1
0.2
Parkinsonism†
5
1.6
3
1.0
4
1.3
7
1.1
Akathisia‡
3
1.0
5
1.6
8
2.6
12
2.1
Dyskinetic event§
0
0.0
0
0.0
1
0.3
1
0.2
Other extrapyramidal event¶
5
1.6
5
1.6
7
2.2
12
1.9
Children and Adolescents: Safety and effectiveness of SEROQUEL XR have not been established in pediatric patients and SE
