. . "\u00DAskal\u00ED a limity kontrolovan\u00FDch studi\u00ED s bipol\u00E1rn\u00ED poruchou" . "Challenges and pitfalls of clinical trials in bipolar disorder"@en . "Suppl. 2" . . "Mohr, Pavel" . . "Nov\u00E1k, Tom\u00E1\u0161" . . "\u00DAskal\u00ED a limity kontrolovan\u00FDch studi\u00ED s bipol\u00E1rn\u00ED poruchou"@cs . "P(1M0517)" . . "Psychiatrie" . . "2"^^ . "RIV/00023752:_____/09:00001012" . "bipolar disorder; randomized controlled trials; placebo; psychotropics."@en . . "K testov\u00E1n\u00ED mo\u017En\u00FDch limit\u016F klinick\u00FDch studi\u00ED u bipol\u00E1rn\u00ED poruchy jsme uskute\u010Dnili systematickou anal\u00FDzu aktu\u00E1ln\u00EDch kontrolovan\u00FDch terapeutick\u00FDch studi\u00ED publikovan\u00FDch v letech 1998-2008. V celkem 78 studi\u00EDch s 15201 pacienty jsme nalezli signifikantn\u011B vy\u0161\u0161\u00ED zastoupen\u00ED \u017Een ve studi\u00EDch s bipol\u00E1rn\u00ED depres\u00ED (p=0,003). P\u0159\u00EDtomnost placebov\u00E9 v\u011Btve nem\u011Bla vliv na d\u00E9lku studie, velikost studijn\u00EDho souboru, pr\u016Fm\u011Brn\u00FD v\u011Bk pacient\u016F, po\u010D\u00E1te\u010Dn\u00ED z\u00E1va\u017Enost onemocn\u011Bn\u00ED nebo procento p\u0159ed\u010Dasn\u00FDch ukon\u010Den\u00ED. V nov\u011Bj\u0161\u00EDch studi\u00EDch s bipol\u00E1rn\u00ED depres\u00ED byl nalezen v\u011Bt\u0161\u00ED po\u010Det p\u0159ed\u010Dasn\u00E9ho ukon\u010Den\u00ED (p=0,002), jsou del\u0161\u00ED (p=0,03) a maj\u00ED vy\u0161\u0161\u00ED zastoupen\u00ED \u017Een (p=0,02) a rychle cykluj\u00EDc\u00EDch pacient\u016F (p=0,02). Nov\u011Bj\u0161\u00ED studie u m\u00E1nie maj\u00ED tak\u00E9 signifikantn\u011B v\u011Bt\u0161\u00ED studovan\u00E9 soubory (p=0,0001). Anal\u00FDza tak\u00E9 uk\u00E1zala na jistou uniformitu pacient\u016F za\u0159azovan\u00FDch do bipol\u00E1rn\u00EDch studi\u00ED, nazna\u010Duj\u00EDc\u00ED potenci\u00E1ln\u00ED bias ve v\u00FDb\u011Bru pacient\u016F. Kontrolovan\u00E9 studie u bipol\u00E1rn\u00ED poruchy tak\u00E9 neodpov\u00EDdaj\u00ED na ot\u00E1zky t\u00FDkaj\u00EDc\u00ED se \u00FA\u010Dinnosti terapie ve specifick\u00FDc" . . "2"^^ . . "\u00DAskal\u00ED a limity kontrolovan\u00FDch studi\u00ED s bipol\u00E1rn\u00ED poruchou" . . . "K testov\u00E1n\u00ED mo\u017En\u00FDch limit\u016F klinick\u00FDch studi\u00ED u bipol\u00E1rn\u00ED poruchy jsme uskute\u010Dnili systematickou anal\u00FDzu aktu\u00E1ln\u00EDch kontrolovan\u00FDch terapeutick\u00FDch studi\u00ED publikovan\u00FDch v letech 1998-2008. V celkem 78 studi\u00EDch s 15201 pacienty jsme nalezli signifikantn\u011B vy\u0161\u0161\u00ED zastoupen\u00ED \u017Een ve studi\u00EDch s bipol\u00E1rn\u00ED depres\u00ED (p=0,003). P\u0159\u00EDtomnost placebov\u00E9 v\u011Btve nem\u011Bla vliv na d\u00E9lku studie, velikost studijn\u00EDho souboru, pr\u016Fm\u011Brn\u00FD v\u011Bk pacient\u016F, po\u010D\u00E1te\u010Dn\u00ED z\u00E1va\u017Enost onemocn\u011Bn\u00ED nebo procento p\u0159ed\u010Dasn\u00FDch ukon\u010Den\u00ED. V nov\u011Bj\u0161\u00EDch studi\u00EDch s bipol\u00E1rn\u00ED depres\u00ED byl nalezen v\u011Bt\u0161\u00ED po\u010Det p\u0159ed\u010Dasn\u00E9ho ukon\u010Den\u00ED (p=0,002), jsou del\u0161\u00ED (p=0,03) a maj\u00ED vy\u0161\u0161\u00ED zastoupen\u00ED \u017Een (p=0,02) a rychle cykluj\u00EDc\u00EDch pacient\u016F (p=0,02). Nov\u011Bj\u0161\u00ED studie u m\u00E1nie maj\u00ED tak\u00E9 signifikantn\u011B v\u011Bt\u0161\u00ED studovan\u00E9 soubory (p=0,0001). Anal\u00FDza tak\u00E9 uk\u00E1zala na jistou uniformitu pacient\u016F za\u0159azovan\u00FDch do bipol\u00E1rn\u00EDch studi\u00ED, nazna\u010Duj\u00EDc\u00ED potenci\u00E1ln\u00ED bias ve v\u00FDb\u011Bru pacient\u016F. Kontrolovan\u00E9 studie u bipol\u00E1rn\u00ED poruchy tak\u00E9 neodpov\u00EDdaj\u00ED na ot\u00E1zky t\u00FDkaj\u00EDc\u00ED se \u00FA\u010Dinnosti terapie ve specifick\u00FDc"@cs . "1"^^ . . . "\u00DAskal\u00ED a limity kontrolovan\u00FDch studi\u00ED s bipol\u00E1rn\u00ED poruchou"@cs . "In order to test the pitfalls and limitations of clinical trials in bipolar disorder, we conducted a systematic review of current controlled treatment trials published between years 1998-2008. In the sample of 78 studies with the total of 15,201 subjects, we found a significantly higher proportion of females in bipolar depression trials (p=0.003). The inclusion of placebo arm did not have a significant impact on the study duration, study sample size, mean age of patients, initial severity of illness or drop-out rate. More recent bipolar depression trials were associated with a higher drop-out rate (p=0.002), were longer (p=0.03), with a higher proportion of females (p=0.02) and rapid cycling patients (p=0.02). More recent mania trials had larger sample sizes (P=0.0001). Our analysis also revealed a uniformity of patients included in bipolar trials, suggesting a potential selection bias. Moreover, controlled trials in bipolar disorder do not provide data on the treatment efficacy in specific patients s"@en . "1211-7579" . . . . "[DAB8C260C73B]" . "Challenges and pitfalls of clinical trials in bipolar disorder"@en . "348031" . "CZ - \u010Cesk\u00E1 republika" . "RIV/00023752:_____/09:00001012!RIV10-MSM-00023752" . "13" .