Efficacy of quetiapine for the treatment of schizophrenia: A combined analysis of three placebo-controlled trials

Peter F Buckley

Research output: Contribution to journalArticle

62 Citations (Scopus)

Abstract

Objective:To determine the effectiveness of quetiapine (Seroquel*) against specific aspects of schizophrenic symptomatology. Research design and methods: Combined data from three placebo-controlled, double-blind, randomised trials that had previously demonstrated quetiapine's overall clinical effectiveness and tolerability were analysed. Efficacy assessments evaluated were the Clinical Global Impression (CGI) Severity of Illness score, Brief Psychiatric Rating Scale (BPRS) factors I-V, BPRS positive symptom cluster score and 18 individual BPRS items. The Simpson-Angus Scale (SAS), the Abnormal Involuntary Movements Scale (AIMS), changes in weight and prolactin concentrations and the recording of adverse events comprised the main tolerability measures. Results: Efficacy assessments were available for a total of 426 quetiapine patients (mean age 36.9 years) with a DSM-IIIR diagnosis of schizophrenia; 502 patients were included in the tolerability analyses. The mean quetiapine dose was 300.5 mg/day with a mean maximum dose of 686.0 mg/day. Quetiapine was efficacious across a broad range of symptoms, including depression, anxiety and hostility. Significant improvements compared with placebo were noted for CGI Severity of Illness (p < 0.001) and in 14 of the 18 individual BPRS items (p < 0.001). Positive symptoms also improved (p < 0.01 at Week 2 and p < 0.001 from Week 3); greater improvements were observed in patients who received at least 400 mg/day quetiapine. Quetiapine was generally well tolerated: 4.0% of patients withdrew from treatment due to adverse events compared with 3.0% of placebo patients. Akathisia occurred in 2.0% and 2.5% of quetiapine and placebo patients, respectively. Similar decreases in prolactin levels for quetiapine (-10.0 μg/L) and placebo (-10.9 μg/L) were noted from baseline to end of treatment. Agitation and headache, the most common adverse events, were comparable in the quetiapine and placebo groups (agitation: 19.3% vs. 20.3%, respectively; headache: 19.1% vs. 17.3%, respectively). Conclusions: The results of this combined analysis confirm the individual findings of the three pivotal studies to demonstrate that quetiapine is effective across several domains of schizophrenia, improving positive, negative and depressive symptoms and reducing agitation, aggression and hostility. Similarly, the analysis reiterated the good tolerability profile of quetiapine, particularly in terms of its placebo-like effects on prolactin levels and incidence of extrapyramidal symptoms (EPS).

Original languageEnglish (US)
Pages (from-to)1357-1363
Number of pages7
JournalCurrent Medical Research and Opinion
Volume20
Issue number9
DOIs
StatePublished - Sep 1 2004

Fingerprint

Schizophrenia
Placebos
Brief Psychiatric Rating Scale
Prolactin
Hostility
Quetiapine Fumarate
Headache
Depression
Psychomotor Agitation
Placebo Effect
Aggression
Research Design
Anxiety
Weights and Measures
Incidence

Keywords

  • BPRS
  • CGI
  • Combined analysis
  • Efficacy
  • Quetiapine

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Efficacy of quetiapine for the treatment of schizophrenia : A combined analysis of three placebo-controlled trials. / Buckley, Peter F.

In: Current Medical Research and Opinion, Vol. 20, No. 9, 01.09.2004, p. 1357-1363.

Research output: Contribution to journalArticle

@article{aec9353731db498686482248f4d69d8b,
title = "Efficacy of quetiapine for the treatment of schizophrenia: A combined analysis of three placebo-controlled trials",
abstract = "Objective:To determine the effectiveness of quetiapine (Seroquel*) against specific aspects of schizophrenic symptomatology. Research design and methods: Combined data from three placebo-controlled, double-blind, randomised trials that had previously demonstrated quetiapine's overall clinical effectiveness and tolerability were analysed. Efficacy assessments evaluated were the Clinical Global Impression (CGI) Severity of Illness score, Brief Psychiatric Rating Scale (BPRS) factors I-V, BPRS positive symptom cluster score and 18 individual BPRS items. The Simpson-Angus Scale (SAS), the Abnormal Involuntary Movements Scale (AIMS), changes in weight and prolactin concentrations and the recording of adverse events comprised the main tolerability measures. Results: Efficacy assessments were available for a total of 426 quetiapine patients (mean age 36.9 years) with a DSM-IIIR diagnosis of schizophrenia; 502 patients were included in the tolerability analyses. The mean quetiapine dose was 300.5 mg/day with a mean maximum dose of 686.0 mg/day. Quetiapine was efficacious across a broad range of symptoms, including depression, anxiety and hostility. Significant improvements compared with placebo were noted for CGI Severity of Illness (p < 0.001) and in 14 of the 18 individual BPRS items (p < 0.001). Positive symptoms also improved (p < 0.01 at Week 2 and p < 0.001 from Week 3); greater improvements were observed in patients who received at least 400 mg/day quetiapine. Quetiapine was generally well tolerated: 4.0{\%} of patients withdrew from treatment due to adverse events compared with 3.0{\%} of placebo patients. Akathisia occurred in 2.0{\%} and 2.5{\%} of quetiapine and placebo patients, respectively. Similar decreases in prolactin levels for quetiapine (-10.0 μg/L) and placebo (-10.9 μg/L) were noted from baseline to end of treatment. Agitation and headache, the most common adverse events, were comparable in the quetiapine and placebo groups (agitation: 19.3{\%} vs. 20.3{\%}, respectively; headache: 19.1{\%} vs. 17.3{\%}, respectively). Conclusions: The results of this combined analysis confirm the individual findings of the three pivotal studies to demonstrate that quetiapine is effective across several domains of schizophrenia, improving positive, negative and depressive symptoms and reducing agitation, aggression and hostility. Similarly, the analysis reiterated the good tolerability profile of quetiapine, particularly in terms of its placebo-like effects on prolactin levels and incidence of extrapyramidal symptoms (EPS).",
keywords = "BPRS, CGI, Combined analysis, Efficacy, Quetiapine",
author = "Buckley, {Peter F}",
year = "2004",
month = "9",
day = "1",
doi = "10.1185/030079904125004510",
language = "English (US)",
volume = "20",
pages = "1357--1363",
journal = "Current Medical Research and Opinion",
issn = "0300-7995",
publisher = "Informa Healthcare",
number = "9",

}

TY - JOUR

T1 - Efficacy of quetiapine for the treatment of schizophrenia

T2 - A combined analysis of three placebo-controlled trials

AU - Buckley, Peter F

PY - 2004/9/1

Y1 - 2004/9/1

N2 - Objective:To determine the effectiveness of quetiapine (Seroquel*) against specific aspects of schizophrenic symptomatology. Research design and methods: Combined data from three placebo-controlled, double-blind, randomised trials that had previously demonstrated quetiapine's overall clinical effectiveness and tolerability were analysed. Efficacy assessments evaluated were the Clinical Global Impression (CGI) Severity of Illness score, Brief Psychiatric Rating Scale (BPRS) factors I-V, BPRS positive symptom cluster score and 18 individual BPRS items. The Simpson-Angus Scale (SAS), the Abnormal Involuntary Movements Scale (AIMS), changes in weight and prolactin concentrations and the recording of adverse events comprised the main tolerability measures. Results: Efficacy assessments were available for a total of 426 quetiapine patients (mean age 36.9 years) with a DSM-IIIR diagnosis of schizophrenia; 502 patients were included in the tolerability analyses. The mean quetiapine dose was 300.5 mg/day with a mean maximum dose of 686.0 mg/day. Quetiapine was efficacious across a broad range of symptoms, including depression, anxiety and hostility. Significant improvements compared with placebo were noted for CGI Severity of Illness (p < 0.001) and in 14 of the 18 individual BPRS items (p < 0.001). Positive symptoms also improved (p < 0.01 at Week 2 and p < 0.001 from Week 3); greater improvements were observed in patients who received at least 400 mg/day quetiapine. Quetiapine was generally well tolerated: 4.0% of patients withdrew from treatment due to adverse events compared with 3.0% of placebo patients. Akathisia occurred in 2.0% and 2.5% of quetiapine and placebo patients, respectively. Similar decreases in prolactin levels for quetiapine (-10.0 μg/L) and placebo (-10.9 μg/L) were noted from baseline to end of treatment. Agitation and headache, the most common adverse events, were comparable in the quetiapine and placebo groups (agitation: 19.3% vs. 20.3%, respectively; headache: 19.1% vs. 17.3%, respectively). Conclusions: The results of this combined analysis confirm the individual findings of the three pivotal studies to demonstrate that quetiapine is effective across several domains of schizophrenia, improving positive, negative and depressive symptoms and reducing agitation, aggression and hostility. Similarly, the analysis reiterated the good tolerability profile of quetiapine, particularly in terms of its placebo-like effects on prolactin levels and incidence of extrapyramidal symptoms (EPS).

AB - Objective:To determine the effectiveness of quetiapine (Seroquel*) against specific aspects of schizophrenic symptomatology. Research design and methods: Combined data from three placebo-controlled, double-blind, randomised trials that had previously demonstrated quetiapine's overall clinical effectiveness and tolerability were analysed. Efficacy assessments evaluated were the Clinical Global Impression (CGI) Severity of Illness score, Brief Psychiatric Rating Scale (BPRS) factors I-V, BPRS positive symptom cluster score and 18 individual BPRS items. The Simpson-Angus Scale (SAS), the Abnormal Involuntary Movements Scale (AIMS), changes in weight and prolactin concentrations and the recording of adverse events comprised the main tolerability measures. Results: Efficacy assessments were available for a total of 426 quetiapine patients (mean age 36.9 years) with a DSM-IIIR diagnosis of schizophrenia; 502 patients were included in the tolerability analyses. The mean quetiapine dose was 300.5 mg/day with a mean maximum dose of 686.0 mg/day. Quetiapine was efficacious across a broad range of symptoms, including depression, anxiety and hostility. Significant improvements compared with placebo were noted for CGI Severity of Illness (p < 0.001) and in 14 of the 18 individual BPRS items (p < 0.001). Positive symptoms also improved (p < 0.01 at Week 2 and p < 0.001 from Week 3); greater improvements were observed in patients who received at least 400 mg/day quetiapine. Quetiapine was generally well tolerated: 4.0% of patients withdrew from treatment due to adverse events compared with 3.0% of placebo patients. Akathisia occurred in 2.0% and 2.5% of quetiapine and placebo patients, respectively. Similar decreases in prolactin levels for quetiapine (-10.0 μg/L) and placebo (-10.9 μg/L) were noted from baseline to end of treatment. Agitation and headache, the most common adverse events, were comparable in the quetiapine and placebo groups (agitation: 19.3% vs. 20.3%, respectively; headache: 19.1% vs. 17.3%, respectively). Conclusions: The results of this combined analysis confirm the individual findings of the three pivotal studies to demonstrate that quetiapine is effective across several domains of schizophrenia, improving positive, negative and depressive symptoms and reducing agitation, aggression and hostility. Similarly, the analysis reiterated the good tolerability profile of quetiapine, particularly in terms of its placebo-like effects on prolactin levels and incidence of extrapyramidal symptoms (EPS).

KW - BPRS

KW - CGI

KW - Combined analysis

KW - Efficacy

KW - Quetiapine

UR - http://www.scopus.com/inward/record.url?scp=5444246449&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=5444246449&partnerID=8YFLogxK

U2 - 10.1185/030079904125004510

DO - 10.1185/030079904125004510

M3 - Article

C2 - 15383183

AN - SCOPUS:5444246449

VL - 20

SP - 1357

EP - 1363

JO - Current Medical Research and Opinion

JF - Current Medical Research and Opinion

SN - 0300-7995

IS - 9

ER -