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We complied inclusion\/exclusion criteria by frequency from reports of 21 RCTs for mania, and applied them in a pilot study of patients hospitalized for DSM\u2010IV BPD manic\/mixed states to compare characteristics and clinical responses of patients who did versus did not meet exclusion criteria. From 27 initially identified inclusion\/exclusion criteria ranked by citation frequency, we derived six inclusion, and 10 non\u2010redundant\u2010exclusion factors. Of 67 consecutive patients meeting inclusion criteria, 15 (22.4%) potential \u201cresearch subjects\u201d met all 10 exclusion criteria. The remaining 52 \u201cclinical patients\u201d differed markedly on exclusion criteria, including more psychiatric co\u2010morbidity, substance abuse, involuntary hospitalization, and suicide attempts or violence, but were otherwise similar. In both groups responses to clinically determined inpatient treatments were similar, including improvement in mania ratings. Based on applying reported inclusion\/exclusion criteria for RCTs to a pilot sample of hospitalized\u2010manic patients, those likely to be included in modern RCTs were similar to patients who would be excluded, most notably in short\u2010term antimanic\u2010treatment responses. The findings encourage further comparisons of subjects included\/excluded from RCTs to test potential clinical generalizability of research findings. The pilot study is limited in numbers and exposure times with which to test for the minor differences between \u201cresearch subjects\u201d and \u201cclinical patients.\u201d Copyright \u00a9 2008 John Wiley &amp; Sons, Ltd.<\/jats:p>","DOI":"10.1002\/hup.952","type":"journal-article","created":{"date-parts":[[2008,5,19]],"date-time":"2008-05-19T10:49:08Z","timestamp":1211194148000},"page":"447-454","source":"Crossref","is-referenced-by-count":9,"title":["Comparison of mania patients suitable for treatment trials versus clinical treatment"],"prefix":"10.1002","volume":"23","author":[{"given":"Alessandra","family":"Talamo","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ross 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