Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

Completed · Phase 3

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

NCT00868959

Run by

Sumitomo Pharma America, Inc.

People needed

817

Starts

2009-04-01

Expected to finish

2013-02-01

Last updated by the study team

2016-04-14

Who can join

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

You may qualify if…

• Subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment
• Subject has completed the 6-week treatment period and all required assessments on the final study visit (Day 42, Visit 8) of either Study D1050235, NCT#00868452 or Study D1050236, NCT#008668699.

You may not qualify if…

• Imminent risk of suicide, injury to self or to others, or damage to property
• Subject has evidence of severe movement disorders.
• Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235, NCT#00868452 or D1050236, NCT#008688699).

Where it is running

• South Coast Clinical Trials Inc. — Anaheim, California, United States
• Catalina Research Institute — Chino, California, United States
• Clinical Innovations Inc. — Costa Mesa, California, United States
• Synergy Escondido — Escondido, California, United States
• Collaborative Neuroscience Network Inc — Garden Grove, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Florida Clinical Research Center LLC — Maitland, California, United States
• Excell Research, Inc — Oceanside, California, United States
• University of California at Irvine Medical Center — Orange, California, United States
• CNRI - Los Angeles LLC — Pico Rivera, California, United States
• Clinical Innovations Inc. — Riverside, California, United States
• California Neuropsychopharmacology Clinical Research Instit — San Diego, California, United States
• Artemis Institute for Clinical Research LLC — San Diego, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• Clinical Innovations Inc. — Santa Ana, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• Collaborative Neuroscience Network Inc. — Torrance, California, United States
• University of Colorado — Aurora, Colorado, United States
• MCB Clinical Research Centers-Colorado Springs — Colorado Springs, Colorado, United States
• Florida Clinical Research Center LLC — Bradenton, Florida, United States
• Florida Clinical Research Center LLC — Fruitland Park, Florida, United States
• Accurate Clinical Trials — Kissimmee, Florida, United States
• Clinical Neuroscience Solutions INc. — Orlando, Florida, United States
• University of South Florida Institute - Tampa — Tampa, Florida, United States
• Woodland International Research Inc — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.