Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Depression

In brief

Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.

Key facts

Study ID

NCT01284517

Run by

Sumitomo Pharma America, Inc.

People needed

356

Starts

2010-11-01

Expected to finish

2012-08-01

Last updated by the study team

2013-11-26

Who can join

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

You may qualify if…

• Provide written informed consent and is 18 to 75 years of age inclusive.
• Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
• Has a lifetime history of at least one bipolar manic or mixed manic episode.
• Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
• Not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
• Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
• Good physical health on the basis of medical history, physical examination, and laboratory screening.

You may not qualify if…

• Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
• Any chronic organic disease of the CNS (other than Bipolar I Disorder).
• Hospitalization for a manic or mixed episode within the past two months.
• Used investigational compound within past 6 months.
• Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.

Where it is running

• Clinical Innovations Inc. — Riverside, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• Clinical Innovations inc. — Santa Ana, California, United States
• Collaborative Neuroscience Network — Torrance, California, United States
• Colorado Clinical Trials Inc. — Highlands Ranch, Colorado, United States
• Accurate Clinical Trials — Kissimmee, Florida, United States
• Clinical Neuroscience Solutions Inc. — Orlando, Florida, United States
• Northwest Behavioral Research Center — Roswell, Georgia, United States
• Institute for Behavioral Medicine LLC — Smyrna, Georgia, United States
• Precise Research Centers — Flowood, Mississippi, United States
• Village Clinical Research Inc. — New York, New York, United States
• Medical & Behavioral Health Research — New York, New York, United States
• Zarzar Psychiatric Associates, PLLC — Raleigh, North Carolina, United States
• Summit Research Network (Oregon) Inc. — Portland, Oregon, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• Clinical Neuroscience Solutions, Inc. — Memphis, Tennessee, United States
• FutureSearch Clinical Trials, LP — Dallas, Texas, United States
• Pillar Clinical Research — Dallas, Texas, United States
• Red Oak Psychiatry Associates, PA — Houston, Texas, United States
• Summit Research Network (Seattle) LLC — Seattle, Washington, United States
• Clinical Research Group Edmonton Inc — Edmonton, Alberta, Canada
• Okanagan Clinical Trials — Kelowna, British Columbia, Canada
• Pierre-Janet Hospital — Gatineau, Quebec, Canada
• Clinical Innovations, Inc. — Costa Mesa, California, United States

Full record on ClinicalTrials.gov

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