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.
Criteria:
- In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
- The subject or, when applicable, the subject's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- The subject suffers 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.
- The subject is a man or woman aged between 18 and 75 years, inclusive.
- The reported duration of the current Major Depressive Episode (MDE) is at least four weeks and less than 6 months.
- The subject has a YMRS total score of ≤10 both at the Screening and Baseline Visits.
- The subject has a MADRS total score of ≥24 at the Screening and Baseline Visits.
- The subject has a CGI-S score of ≥4 at the Screening and Baseline Visits.
- The subject has HAM- A total score of ≤21 at Screening and Baseline Visits.
- The subject is on lithium and/or one other mood stabilizer (lamotrigine or valproic acid) and/or one atypical antipsychotic (risperidone or olanzapine or aripiprazole or ziprasidone). Patients may be on one, two, or three medications but no more than one from each group.
- The subject is on the same dose of the protocol allowed medications (identified in inclusion # 10) 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 the subject is on lithium and/or valproic acid, the trough serum levels must be 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.
- The subject screened must have <25% improvement in MADRS total score from screening to baseline visit with a minimum of two weeks between screening and baseline visits.
- A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees 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.
- A male subject who is nonsterilized and sexually active with female partner of childbearing potential agrees 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:
Free medication, free evaluations, and compensation for time and travel.