Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Depression

In brief

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.

Key facts

Study ID

NCT00868452

Run by

Sumitomo Pharma America, Inc.

People needed

348

Starts

2009-04-01

Expected to finish

2012-01-01

Last updated by the study team

2014-04-17

Who can join

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

You may qualify if…

• Subject is diagnosed with bipolar I disorder, most resent episode depressed
• Subject must have a lifetime history of at least one bipolar manic or mixed episode
• Subject must be taking lithium or divalproex at least 28 days prior to screening

You may not qualify if…

• History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
• Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
• Imminent risk of suicide or injury to self, others, or property

Where it is running

• South Coast Clinical Trials, Inc. — Anaheim, California, United States
• Catalina Research Institute — Chino, California, United States
• Synergy Escondido — Escondido, California, United States
• Collaborative Neuroscience Network Inc.,12772 Valley View Street — Garden Grove, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California at Irvine Medical Center — Orange, California, United States
• CNRI - Los Angeles LLC,8309 Telegraph Road — Pico Rivera, California, United States
• CNRI - San Diego, LLC — San Diego, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• University of Colorado — Aurora, Colorado, United States
• Depression and Anxiety Disorders Research Institue — Tampa, Florida, United States
• American Medical Research Inc.,1200 Harger Road Suite 415 — Oak Brook, Illinois, United States
• American Medical Research, Inc., 1200 Harger Road Suite 415 — Oak Brook, Illinois, United States
• J. Gary Booker, MD — Shreveport, Louisiana, United States
• Sheppard Pratt Health System,6501 North Charles Street — Baltimore, Maryland, United States
• Capital Clinical Research,5515 Security Lane, Suite 525 — Rockville, Maryland, United States
• Midwest Research Group — Saint Charles, Missouri, United States
• Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209 — Albuquerque, New Mexico, United States
• Lake Charles Clinical Trials LLC,700 Spring Forest Road — Raleigh, North Carolina, United States
• Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125 — Raleigh, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Mood Disorders Program-UHCMC — Cleveland, Ohio, United States
• MetroHealth System — Cleveland, Ohio, United States
• Midwest Clinical research Center, One Elizabeth Place, Suite G-3 — Dayton, Ohio, United States
• Woodland International Research Inc. — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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