Major Depressive Disorder With Mixed Features (RESOLVE2)

Sumitomo Pharma

Status and phase

Withdrawn

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: Lurasidone 20 mg

Drug: Lurasidone 60 mg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01423240

D1050305

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.