Summary:
A randomized, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of once a day, tak-375 (ramelteon) tablet for sublingual administration (tak-375sl tablet) as an adjunctive therapy in the treatment of acute depressive episodes associated with Bipolar 1 Disorder in adult subjects.
Qualified Participants Must:
• Be capable of understanding and complying with protocol requirements
•
Suffer from Bipolar 1 Disorder, Most Recent Episode Depressed as the primary diagnosis according to DSM-IV-TR criteria (classification code 296.5x) and confirmed by the SCID
•
Be between 18 and 75 years of age
•
Have experienced a Major Depressive Episode (MDE) lasting at least four weeks and less than 6 months
•
Have a YMRS total score of ≤10 both at the Screening and Baseline Visit
•
Have a MADRS total score of ≥24 at the Screening and Baseline Visits
•
Have a CGI-S score of ≥4 at the Screening and Baseline Visits
•
Have a HAM- A total score of ≤21 at Screening and Baseline Visits
•
Be taking lithium and/or one other mood stabilizer (lamotrigine or valproic acid) and/or one atypical antipsychotic (risperidone or olanzapine or aripiprazole or ziprasidone)
•
Be on the same dose of the allowed medications (identified above) for bipolar 1 disorder for at least two weeks prior to screening (and at least 6 weeks prior to screening for lamotrigine only). Further dose adjustments will not be allowed from screening until end of study, except for downward dose adjustments for adverse events
•
If on lithium and/or valproic acid, have trough serum levels less than 1.2 mEq/L for lithium and the trough serum must be less than 125 mcg/ml for valproic acid. Downward dose adjustment is allowed to lower trough serum levels for lithium and/or valproic acid below the maximum allowed. This must be confirmed at least two weeks prior to baseline
•
Have <25% improvement in MADRS total score from screening to baseline visit with a minimum of two weeks between screening and baseline visits
•
If female subject is of childbearing potential and sexually active with a nonsterilized male partner must agree to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose of the study drug
•
If male subject who is nonsterilized and sexually active with female partner of childbearing potential must agree to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose of study drug
Qualified Participants May Receive:
Compensation and free study related procedures.