Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Lurasidone Hydrochloride

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.