Major Depressive Disorder With Mixed Features - Extension
RESOLVE3
A 12-Week, Open-Label Extension Study For the Treatment of Major Depressive Disorder With Mixed Features
1 other identifier
interventional
48
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 major-depressive-disorder
Started Sep 2011
Typical duration for phase_3 major-depressive-disorder
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2011
CompletedFirst Posted
Study publicly available on registry
August 25, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
October 14, 2015
CompletedApril 8, 2016
March 1, 2016
2.1 years
August 23, 2011
September 15, 2015
March 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)
Percentage of subjects with treatment emergent adverse events (TEAEs)
12 Weeks
Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)
Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)
12 Weeks
Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)
Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)
12 Weeks
Secondary Outcomes (5)
Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores
Baseline to12 Weeks
Change From Baseline to Week 12 (LOCF) in CGI-S Score
baseline to week 12
Change From Baseline to Week 12 (LOCF) in the YMRS Total Score
Baseline to week 12
Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score
Baseline to week 12
Change From Baseline to Week 12 (LOCF) in the SDS Total Score
Baseline to week 12
Study Arms (1)
Lurasidone 20, 40, 60 mg
EXPERIMENTALLurasidone 20, 40, or 60 mg/day flexibly dosed
Interventions
Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Birmingham Psychiatry Pharmaceutical Studies, Inc
Birmingham, Alabama, 35226, United States
Synergy Clinical Research Center
Escondido, California, 92025, United States
Collaborative Neuro Science Network, Inc.
Garden Grove, California, 92845, United States
Stanford -VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Florida Clinical Research Center, LLC
Sarasota, Florida, 34201, United States
Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders
Boston, Massachusetts, 02114, United States
St. Charles Psychiatric Associates/Midwest Research Group
Saint Charles, Missouri, 63301, United States
Village Clinical Research Inc.
New York, New York, 10003, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Behavioral Medical Research of Staten Island
Staten Island, New York, 10305, United States
Psychiatry and Behavioral Sciences, Duke
Durham, North Carolina, 27705, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
CRI Worldwide - Kirkbride
Philadelphia, Pennsylvania, 19139, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231, United States
Dept. of Psychiatry, UT Southwestern Medical Center
Dallas, Texas, 75390-8849, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- 1-866-503-6351
- Organization
- Sunovion
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2011
First Posted
August 25, 2011
Study Start
September 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
April 8, 2016
Results First Posted
October 14, 2015
Record last verified: 2016-03