Major Depressive Disorder With Mixed Features - Extension

Completed · Phase 3

Conditions studied: Major Depressive Disorder

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 over time.

Key facts

Study ID

NCT01423253

Run by

Sumitomo Pharma America, Inc.

People needed

48

Starts

2011-09-01

Expected to finish

2013-10-01

Last updated by the study team

2016-04-08

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 has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study D1050305 (NCT#01423240).
• Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

You may not qualify if…

• Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at baseline (Day 43 in Study D1050304 or D1050305).
• Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.

Where it is running

• Birmingham Psychiatry Pharmaceutical Studies, Inc — Birmingham, Alabama, United States
• Synergy Clinical Research Center — Escondido, California, United States
• Collaborative Neuro Science Network, Inc. — Garden Grove, California, United States
• Stanford -VA Palo Alto Health Care System — Palo Alto, 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
• 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

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.