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

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 for the treatment of patients with bipolar I depression

Key facts

Study ID

NCT00868699

Run by

Sumitomo Pharma America, Inc.

People needed

505

Starts

2009-04-01

Expected to finish

2012-02-01

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

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

• Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3 — Garden Grove, California, United States
• Excell Research, Inc,3998 Vista Way,Suite 100 — Oceanside, California, United States
• University of California at Irvine Medical Center — Orange, California, United States
• California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road — Pico Rivera, California, United States
• California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor — San Diego, California, United States
• University of Colorado — Aurora, Colorado, United States
• Florida Clinical Research Center, LLC,3914 State Road 64 East — Bradenton, Florida, United States
• Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230 — Maitland, Florida, United States
• Depression and Anxiety Disorders Research Institute — Tampa, Florida, United States
• Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103 — West Palm Beach, Florida, United States
• American Medical Research Inc.,1200 Harger Road Suite 415 — Oak Brook, Illinois, United States
• Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340 — Lake Charles, Louisiana, United States
• Sheppard Pratt Health System,6501 North Charles Street — Baltimore, Maryland, United States
• Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209 — Albuquerque, New Mexico, United States
• Neurobehavioral Research, Inc. — Cedarhurst, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125 — Raleigh, North Carolina, United States
• Mood Disorders Program-UHCMC — Cleveland, Ohio, United States
• MetroHealth System — Cleveland, Ohio, United States
• CRI Worldwide, LLC — Philadelphia, Pennsylvania, United States
• FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200 — Austin, Texas, United States
• Medical Services Prague s.r.o. — Kolejni 429-5, Prague, Czechia
• Psychiatricka ambulance — Brno - Mesto, Czechia
• BIALBI s.r.o., Psychiatricke Oddeleni — Litoměřice, Czechia
• Synergy Escondido,710 East Grand Ave. — Escondido, California, United States

Full record on ClinicalTrials.gov

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