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

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder With Mixed Features

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

NCT01421134

Run by

Sumitomo Pharma America, Inc.

People needed

211

Starts

2011-09-01

Expected to finish

2014-10-01

Last updated by the study team

2016-07-15

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 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)

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 Psychiatry Pharmaceutical Studies, Inc. — Birmingham, Alabama, United States
• Synergy Clinical Research Center — Escondido, California, United States
• Collaborative Neuroscience Network Inc. — Garden Grove, California, United States
• Stanford -VA Palo Alto Health Care System — Palo Alto, California, United States
• Clinical Innovations Inc. — Riverside, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Florida Clinical Research Center, LLC — Sarasota, Florida, United States
• Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders — Boston, Massachusetts, United States
• St. Charles Psychiatric Associates/Midwest Research Group — Saint Charles, Missouri, United States
• Social Psychiatric Research Inst. (SPRI) Clinical Trials — Brooklyn, New York, United States
• Village Clinical Research Inc. — New York, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Behavioral Medical Research of Staten Island — Staten Island, New York, United States
• Psychiatry and Behavioral Sciences, Duke — Durham, North Carolina, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• CRI Worldwide - Kirkbride — Philadelphia, Pennsylvania, United States
• FutureSearch Trials of Dallas, LP — Dallas, Texas, United States
• Dept. of Psychiatry, UT Southwestern Medical Center — Dallas, Texas, United States
• Grayline Clinical Drug Trials — Wichita Falls, Texas, United States
• Saint Nicholas Psychiatric Hospital. — Saint Petersburg, Russia
• City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit) — Saint Petersburg, Russia
• Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva" — Saint Petersburg, Russia
• Municipal Healthcare Institution"City Clinical Hospital #2, n.a. V.I. Razumovsky" of Healthcare Committee of Administration of Municipal Entity "City of Saratov" — Saratov, Russia
• State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia, — Saratov, Russia
• Limited Liability Company "Research-And-Educational Centre of Psychotherapy "Podderzhka" — Stavropol, Russia

Full record on ClinicalTrials.gov

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