Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
Condition: Major Depressive Disorder With Mixed Features
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Lurasidone; Placebo
Intervention description: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks; Placebo
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 211.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: depression; Lurasidone; Latuda

Summary:

      Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with
      mixed features.This clinical study is designed to test how well Lurasidone works to treat
      major depressive disorder with mixed features.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject provides written informed consent and is willing and able to comply with the
             protocol in the opinion of the Investigator.

          -  Subject is 18 to 75 years of age, inclusive.

          -  Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical
             Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]).

          -  Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR;
             at least 2 weeks in duration) AND two or three of the following manic symptoms
             occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT
             modified for Study D1050304):

               -  Elevated, expansive mood

               -  Inflated self-esteem or grandiosity

               -  More talkative than usual or pressure to keep talking

               -  Flight of ideas or subjective experience that thoughts are racing

               -  Increase in energy or goal-directed activity (either socially, at work or school,
                  or sexually)

               -  Increased or excessive involvement in activities that have a high potential for
                  painful consequences (e.g., engaging in unrestrained buying sprees, sexual
                  indiscretions, or foolish business investments)

               -  Decreased need for sleep (feeling rested despite sleeping less than usual; to be
                  contrasted from insomnia)

        Exclusion Criteria:

          -  Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus
             of treatment within the 3 months prior to screening.

          -  Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of
             evaluation) at screening or baseline visit.

          -  Subject has attempted suicide within the past 3 months.

          -  Subject has a lifetime history of any bipolar I manic or mixed manic episode.

          -  Subject has any abnormal laboratory parameter at screening that indicates a clinically
             significant medical condition as determined by the Investigator.