Quetiapine in patients with schizophrenia - A high- and low-dose double-blind comparison with placebo

被引:0
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作者
Small, JG
Hirsch, SR
Arvanitis, LA
Miller, BG
Link, CGG
Murphy, AL
Bowden, CL
OBrien, CP
Steinbook, RM
Wagner, RL
Pitts, WM
Crabtree, B
Corrigan, MHN
Lohr, JB
Miller, AL
Ereshefsky, L
Anderson, CB
Knesevich, MA
Rotrosen, J
Owen, RR
Karson, CN
Lindenmayer, JP
Pfefferbaum, A
Faustman, WO
Keck, PE
Patterson, WM
Riesenberg, RA
Gladson, MB
Kolin, IS
Barnes, TRE
Sensky, T
Riccio, M
Franks, S
Jolley, A
Hallstrom, C
Bennie, E
Darcourt, G
Patris, M
DeSilva, M
Patel, AG
Fleischhacker, WW
Dietzel, M
Seifertova, D
Vinar, O
Faltus, F
Bitter, I
Ozsvath, K
Shaw, SH
Mahapatra, SN
Szulecka, TK
机构
[1] LARUE D CARTER MEM HOSP, DIV MENTAL HLTH, INDIANAPOLIS, IN USA
[2] CHARING CROSS HOSP, DEPT PSYCHIAT, LONDON, ENGLAND
[3] ZENECA PHARMACEUT, DEPT CLIN & MED AFFAIRS, WILMINGTON, DE USA
[4] ZENECA PHARMACEUT, DEPT MED AFFAIRS, MACCLESFIELD, CHESHIRE, ENGLAND
[5] VET MEM HOSP, SAN ANTONIO, TX USA
[6] VET AFFAIRS MED CTR, PHILADELPHIA, PA USA
[7] UNIV MIAMI, JACKSON MEM MED CTR, MIAMI, FL 33101 USA
[8] INST MENTAL HLTH, CRANSTON, RI USA
[9] UNIV MISSISSIPPI, MED CTR, JACKSON, MS 39216 USA
[10] VET AFFAIRS MED CTR, JACKSON, MS USA
[11] DOROTHEA DIX HOSP, RALEIGH, NC USA
[12] VET AFFAIRS MED CTR, SAN DIEGO, CA 92161 USA
[13] UNIV TEXAS, HLTH SCI CTR, SAN ANTONIO, TX USA
[14] SAN ANTONIO STATE HOSP, SAN ANGELO, TX USA
[15] CLIN PHARM PROGRAMS, SAN ANTONIO, TX USA
[16] TERRELL STATE HOSP, TERRELL, TX USA
[17] NEW YORK VET AFFAIRS MED CTR, NEW YORK, NY USA
[18] VET AFFAIRS MED CTR, LITTLE ROCK, AR USA
[19] ARKANSAS STATE HOSP, LITTLE ROCK, AR USA
[20] SCHIZOPHREN RES UNIT, BRONX, NY USA
[21] STANFORD VET AFFAIRS MENT HLTH CLIN RES CTR, PALO ALTO, CA USA
[22] UNIV CINCINNATI, COLL MED, CINCINNATI, OH USA
[23] HILLCREST HOSP, BIRMINGHAM RES GRP, BIRMINGHAM, AL USA
[24] DEKALB MED CTR, DECATUR, GA USA
[25] SAND LAKE HOSP, ORLANDO, FL USA
[26] HORTON HOSP, SURREY, ENGLAND
[27] W MIDDLESEX HOSP, ISLEWORTH, MIDDX, ENGLAND
[28] ST MARY ABBOT HOSP, LONDON, ENGLAND
[29] GORDON HOSP, LONDON, ENGLAND
[30] EALING GEN HOSP, LONDON, MIDDX, ENGLAND
[31] CHARING CROSS HOSP, LONDON, ENGLAND
[32] LEVERNADALE HOSP, GLASGOW, LANARK, SCOTLAND
[33] PASTEUR HOSP, CLIN PSYCHIAT & PSYCOL, NICE, FRANCE
[34] PSYCHIAT CLIN, STRASBOURG, FRANCE
[35] UNIV INNSBRUCK CLIN, INNSBRUCK, AUSTRIA
[36] UNIV VIENNA, PSYCHIAT CLIN, A-1090 VIENNA, AUSTRIA
[37] INST PSYCHIAT RES, PRAGUE, CZECH REPUBLIC
[38] HOSP PSYCHIAT, PRAGUE, CZECH REPUBLIC
[39] CHARLES UNIV, PRAGUE, CZECH REPUBLIC
[40] SEMMELWEIS UNIV MED, H-1085 BUDAPEST, HUNGARY
[41] UNIV PECS, SCH MED, PECS, HUNGARY
[42] GEN HOSP, HARTLEPOOL, ENGLAND
[43] BASSETLAW DISTRICT GEN HOSP, NOTTINGHAM, ENGLAND
[44] HALIFAX GEN HOSP, HALIFAX, W YORKSHIRE, ENGLAND
[45] ST MARYS PSYCHIAT HOSP, CASLEBAR, MAYO, IRELAND
[46] ST LUKES HOSP, CLONMEL, TIPPERARY, IRELAND
[47] PSYCHIAT KLIN, DUSSELDORF, GERMANY
[48] QUEENS UNIV BELFAST, BELFAST, ANTRIM, NORTH IRELAND
[49] UNIV CLIN VIENNA, VIENNA, AUSTRIA
关键词
D O I
暂无
中图分类号
R749 [精神病学];
学科分类号
100205 ;
摘要
Background: Quetiapine fumarate (Seroquel [ICI 204,636]) is an atypical dibenzothiazepine antipsychotic with a greater affinity for 5-hydroxytryptamine(2) (5-HT2) receptors than for D-2 dopamine receptors; its efficacy in patients with schizophrenia was shown in early phase 2 trials (maximum dose, 750 mg/d). Methods: In this multicenter, double-blind, placebo-controlled trial, 286 patients hospitalized with chronic or subchronic schizophrenia (DSM-III-R) were randomized to 6 weeks of treatment with high-dose quetiapine fumarate (less than or equal to 750 mg/d), n = 96; low-dose quetiapine fumarate (less than or equal to 250 mg/d), n = 94; or placebo, n = 96. The Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression Severity of Illness item scores were the primary efficacy variables. Secondary efficacy variables included the BPRS positive-symptom cluster score, the Modified Scale for the Assessment of Negative Symptoms summary score (United States only), and the total score from the negative scale of the Positive and Negative Syndrome Scale (Europe only). Scores were analyzed using an analysis of covariance for change from baseline at end point with last observations carried forward. The model included baseline score (covariate), center, and treatment. Extrapyramidal symptoms were assessed using the Simpson-Angus Scale and the Barnes Akathisia Scale; abnormal involuntary movements were assessed using the Abnormal Involuntary Movement Scale. Frequency distributions of grouped change-from-baseline scores were analyzed using chi(2) tests. Results: Of 280 patients in whom the efficacy of quetiapine was evaluated, 159 (42% of those receiving high-dose treatment; 57%, low-dose treatment; and 59%, placebo) withdrew before trial completion, primarily because of treatment failure. Significant (P < .001, BPRS; P = .003, Clinical Global Impression Severity of Illness item; and P = .003, BPRS positive-symptom cluster) differences were identified between patients receiving high-dose quetiapine and placebo for both primary efficacy variables, with end point differences in the BPRS positive-symptom cluster score showing quetiapine's consistency in reducing positive symptoms. The reduction of negative symptoms was less consistent; high-dose quetiapine was superior on the Modified Scale for the Assessment of Negative Symptoms but not on the negative scale of the Positive and Negative Syndrome Scale. Quetiapine was well tolerated and did not induce extrapyramidal symptoms, sustained elevations of prolactin, or clinically significant changes in hematologic parameters. Conclusions: Quetiapine is an effective antipsychotic with a favorable safety profile. The optimum dose is probably greater than 250 mg/d.
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收藏
页码:549 / 557
页数:9
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