Major Depressive Disorder With Mixed Features

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
D1050305):

- 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) Subject has a rater-administered Montgomery-Asberg
Depression Rating Scale (MADRS) total score of ≥ 26 at screening and both a
rater-administered and self-rated (administered by computer) MADRS total score ≥ 26
at baseline.

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.