Moclobemide in social phobia - A double-blind, placebo-controlled clinical study

被引:0
作者
Burrows, G [1 ]
Evans, L [1 ]
Baumhackl, U [1 ]
Hebenstreit, H [1 ]
Katschnig, H [1 ]
Schony, W [1 ]
Scholz, H [1 ]
Wilmotte, J [1 ]
Campos, J [1 ]
Costa, D [1 ]
Nardi, A [1 ]
Versiani, M [1 ]
daSilva, A [1 ]
Bowen, R [1 ]
Bradwejn, J [1 ]
Johnston, D [1 ]
Plamondon, J [1 ]
Stein, M [1 ]
Swinson, R [1 ]
Chneiweiss, L [1 ]
Bellaire, W [1 ]
Osterheider, M [1 ]
Sonntag, R [1 ]
Cookson, J [1 ]
Freeman, C [1 ]
Hirsch, S [1 ]
Mullin, J [1 ]
Murray, R [1 ]
Nutt, D [1 ]
Petursson, H [1 ]
ODonoghue, F [1 ]
Min, J [1 ]
Allgulander, C [1 ]
Andersch, S [1 ]
Backa, H [1 ]
Realini, R [1 ]
Siegel, JL [1 ]
Buller, R [1 ]
Katschnig, H [1 ]
Stein, MB [1 ]
Buller, R [1 ]
机构
[1] UNIV VIENNA, DEPT PSYCHIAT, A-1090 VIENNA, AUSTRIA
关键词
moclobemide; social phobia; double-blind clinical study; placebo; dose-response;
D O I
暂无
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
The primary objectives of this large multicenter study (n=578) were to determine the efficacy and safety of moclobemide, 300 or 600 mg per day, for the treatment of social phobia. A double-blind fixed-dose parallel group study was conducted to compare the two different doses of moclobemide to placebo. After a 1-week placebo run-in period, patients were randomly assigned to one of the three treatment groups to receive the test compound for a 12-week period. Assessments were performed at screen, on baseline and on weeks 1, 2, 3, 4, 6, 8, 10, and 12. There were consistent, reliable and clinically meaningful drug effects and indications of a dose-response relationship. Statistical analysis of the results at both weeks 8 and 12 showed that 600 mg of moclobemide was effective and statistically significantly superior to placebo. The 300 mg dose also showed better efficacy than placebo on all measures of efficacy, and about half of them were statistically significantly different from placebo. Moclobemide was well tolerated. Adverse events, except for insomnia, were neither dose-related nor were there significant drug-placebo differences. The results indicate that 600 mg of moclobemide per day given b.i.d. is effective in social phobia, reducing the symptoms and the impairment associated with the disorder. The compound is well tolerated and safe.
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页码:71 / 80
页数:10
相关论文
共 37 条
[1]   SOCIAL PHOBIA - A COMPARATIVE CLINICAL-STUDY [J].
AMIES, PL ;
GELDER, MG ;
SHAW, PM .
BRITISH JOURNAL OF PSYCHIATRY, 1983, 142 (FEB) :174-179
[2]  
[Anonymous], 1992, INT CLASS DIS
[3]   MOCLOBEMIDE IN SOCIAL PHOBIA - A PILOT OPEN STUDY [J].
BISSERBE, JC ;
LEPINE, JP ;
LEGOUBEY, P ;
RIGAUD, P ;
ALBERT, E ;
CHNEWEISS, L ;
RIOUX, P .
CLINICAL NEUROPHARMACOLOGY, 1994, 17 :S88-S94
[4]  
DAVIDSON JRT, 1993, J CLIN PSYCHOPHARM, V13, P423
[5]   THE EPIDEMIOLOGY OF SOCIAL PHOBIA - FINDINGS FROM THE DUKE EPIDEMIOLOGIC CATCHMENT-AREA STUDY [J].
DAVIDSON, JRT ;
HUGHES, DL ;
GEORGE, LK ;
BLAZER, DG .
PSYCHOLOGICAL MEDICINE, 1993, 23 (03) :709-718
[6]  
FAHLEN T, 1992, CLIN NEUROPHARMAC S1, V15, pB64
[7]  
First MB, 1995, STRUCTURED CLIN INTE
[8]  
GELERNTER CS, 1991, ARCH GEN PSYCHIAT, V48, P938
[9]  
GELERNTER CS, 1992, J CLIN PSYCHIAT, V53, P23
[10]  
GREIST J, 1995, ARCH GEN PSYCHIAT, V52, P289