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COMPLETEDPhase 3NCT01423253

Major Depressive Disorder With Mixed Features - Extension

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 d...

Lead sponsor: Sumitomo Pharma America, Inc.•17 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Sumitomo Pharma America, Inc.

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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.

Exclusion Criteria

•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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 8, 2016Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment48

Start dateSep 2011

Last updatedApr 8, 2016

Condition

Major Depressive Disorder

Locations shown

Birmingham Psychiatry Pharmaceutical Studies, Inc

Birmingham, Alabama

Synergy Clinical Research Center

Escondido, California

Collaborative Neuro Science Network, Inc.

Garden Grove, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2016Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions