A 3-Week, Open Label Study to Evaluate the Efficacy and Safety of Extended Release Quetiapine Fumarate in the Treatment of Agitation in Patients with Schizophrenia
Objective: To evaluate the efficacy of extended-release quetiapine fumarate (XR) monotherapy once daily, in the treatment of patients with acute episodes of schizophrenia and agitation. Method: Our study was a 3-week open-label study conducted in adult in- or outpatients with schizophrenia. Quetia...
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Main Authors: | , , , , , |
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Format: | Article |
Language: | English |
Published: |
Taylor & Francis
2013
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Subjects: | |
Online Access: | http://eprints.um.edu.my/9622/1/00000797_93562.pdf http://eprints.um.edu.my/9622/ https://doi.org/10.5455/bcp.20130127022922 |
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Summary: | Objective: To evaluate the efficacy of extended-release
quetiapine fumarate (XR) monotherapy once daily, in the treatment of patients with acute episodes of schizophrenia and agitation.
Method: Our study was a 3-week open-label study conducted in adult in- or outpatients with schizophrenia. Quetiapine XR was initiated at 300 mg on day 1, 600mg on day 2, and 400-800 mg (at the investigator’s discretion) on day 3 and onwards. The primary endpoint was the change from baseline in the Positive and Negative Syndrome Scale Excited Component (PANSSEC) score. Secondary endpoints included change from baseline in PANSS-Positive, PANSS-Negative, PANSSGeneral Psychopathological (PANSS-G) subscale scores,
total PANSS score, PANSS aggression, hostility and
depression cluster scores, CGI-Severity of illness (CGIS)
and the absolute CGI-Improvement (CGI-I) scales. Tolerability was assessed based on reported adverse
events (AEs), the Simpson-Angus Scale (SAS) and
Barnes Akathisia Rating Scale (BARS) scores, laboratory
measurements and electrocardiograms (ECGs).
Results: Of 40 patients enrolled, 35 completed the
study. At day 21, statistically significant improvements
versus baseline were seen for the primary and all
secondary endpoints assessed. The incidence of AEs
was low, and all were mild to moderate in severity. No
extrapyramidal symptoms (EPS) as measured by the SAS
and BARS were reported, indicating that the treatment
was well tolerated. Hospitalization was required in one
out-patient due to a relapse of psychosis, but was not
considered to be treatment related.
Conclusion: Once-daily quetiapine fumarate XR (400-
800 mg/day) was effective in reducing agitation and a broad range of symptoms in acute schizophrenia.
Treatment, including rapid dose escalation, was
generally well tolerated in this study. |
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