A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-reduction Paradigm in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-reduction Paradigm in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/day
Inclusion Criteria:
Exclusion Criteria:
Anaheim, California 92804, United States
Garden Grove, California 92845, United States
Colorado Springs, Colorado 80910, United States
Hallandale, Florida 33009-4427, United States
Winfield, Illinois 60190, United States
Saint Charles, Missouri 63304, United States
Columbus, Ohio 43210, United States
Pleven, 5800, Bulgaria
Gdansk, Pomeranian Voivodeship 80-546, Poland
Poznan, Silesian Voivodeship 60-744, Poland
Roschino, 188820, Russia
Saint Petersburg, 192019, Russia
Saint Petersburg, 192019, Russia
Tonnelniy, 357034, Russia
Novi Kneževac, 23330, Serbia
Taipei City, Taipei 11217, Taiwan
Muang, 50100, Thailand
Kryvbas Village, Dnipropetrovsk Oblast 53054, Ukraine
Kharkiv, Kharkiv Oblast 61068, Ukraine
Kharkiv, Kharkiv Oblast 61068, Ukraine
Kharkiv, Kharkiv Oblast 61068, Ukraine
Stepanivka Village, Kherson Oblast 73488, Ukraine
Oleksandrivka Village, Odesa Oblast 67513, Ukraine
Uzhhorod, Zakarpattia Oblast 88000, Ukraine
Lviv, 79021, Ukraine
Vinnytsia, 21005, Ukraine