Major Depressive Disorder With Mixed Features

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01423240

Run by

Sumitomo Pharma America, Inc.

People needed

0

Starts

2012-01-01

Expected to finish

2012-12-01

Last updated by the study team

2012-12-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Birmingham Research Group — Birmingham, Alabama, United States
• Sun Valley Behavioral Medical — Imperial, California, United States
• Synergy Clinical Research Center — National City, California, United States
• Excell Research — Oceanside, California, United States
• Pacific Clinical Research Medical Group — Orange, California, United States
• SMRI — Sherman Oaks, California, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Florida Research Center — Maitland, Florida, United States
• University of Miami, Miller School — Miami, Florida, United States
• Miami Research — Miami, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Comprehensive NeuroScience Inc. — Atlanta, Georgia, United States
• Hawaii Clinical Research Center — Honolulu, Hawaii, United States
• Psychiatric Medicine Associates — Skokie, Illinois, United States
• Goldpoint Clinical Research — Indianapolis, Indiana, United States
• CRI Worldwide — Willingboro, New Jersey, United States
• Medical & Behavioral Health Research — New York, New York, United States
• Montefiore Medical Center; Anxiety & Depression Clinic; Dept. of Psychiatry — The Bronx, New York, United States
• New Hope Clinical Research — Hickory, North Carolina, United States
• Sooner Clinical Research — Oklahoma City, Oklahoma, United States
• Lehigh Center for Clinical Research — Allentown, Pennsylvania, United States
• Suburban Research Associates — Media, Pennsylvania, United States
• Harry Croft and Associates — San Antonio, Texas, United States
• University of Texas Health Science Center — San Antonio, Texas, United States
• Grayline Clinical Drug Trials — Wichita Falls, Texas, United States

Full record on ClinicalTrials.gov

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