"Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder"@en. "A Phase IIIb, Randomized, Double-Blind, Parallel Group Study in Bipolar I Patients to Assess the Efficacy and Safety of SPD417 Administered Once Daily vs Twice Daily in the Treatment of Manic Symptoms"@en. . "NCT00150553"@en. . "102"^^. "2005-01". "Source: Freebase - The World's database". . "Women of childbearing potential agree to take adequate precautions against contraception"@en. "DSM-IV criteria for bipolar I disorder"@en. "Screen YMRS score => 16"@en. . . . . . . . . . . . "2005-10". . "18"^^. "Time to remission"@en. "HAM-D and MADRS scales for depression"@en. "Clinical Global Impressions Scale - Bipolar Version"@en. . . "Hospitalization required for treatment of psychiatric symptoms"@en. "History of serious suicide attempt requiring medical intervention"@en. "Patients who meet DSM-IV for ultra-rapid cycling"@en. "Score on Young Mania Rating Scale (YMRS) at 12 weeks"@en. . . . "http://clinicaltrials.gov/ct2/show/NCT00150553". . . . "ClinicalTrials.gov"@en.