Major Depressive Disorder With Mixed Features
RESOLVE2
A Randomized, 6-week, Double-blind, Placebo-controlled, Fixed-dose, Parallel Group Study of Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features
1 other identifier
interventional
N/A
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2012
Shorter than P25 for phase_3 major-depressive-disorder
27 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
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 13, 2012
December 1, 2012
11 months
August 23, 2011
December 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MADRS
Mean change from baseline in MADRS total score after 6 weeks of treatment
6 weeks
Secondary Outcomes (1)
CGI-S
6 weeks
Study Arms (3)
Lurasidone 20 mg
EXPERIMENTALLurasidone 60 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Lurasidone 20 mg once daily orally in the evening
Lurasidone 60 mg once daily orally in the evening
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 is 18 to 75 years of age, inclusive. Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured Clinical Interview for DSM-IV Disorders - Clinical Trial version \[SCID-CT\]).
- Subject is currently experiencing a major depressive episode (diagnosed by DSM-IV-TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050305):
- Elevated, expansive mood
- Inflated self-esteem or grandiosity
- More talkative than usual or pressure to keep talking
- Flight of ideas or subjective experience that thoughts are racing
- Increase in energy or goal-directed activity (either socially, at work or school, or sexually)
- Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
- Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia) Subject has a rater-administered Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and both a rater-administered and self-rated (administered by computer) MADRS total score ≥ 26 at baseline.
You may not qualify if:
- Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.
- Subject has attempted suicide within the past 3 months. Subject has a lifetime history of any bipolar I manic or mixed manic episode. Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Birmingham Research Group
Birmingham, Alabama, 35216, United States
Sun Valley Behavioral Medical
Imperial, California, 92251, United States
Synergy Clinical Research Center
National City, California, 91950, United States
Excell Research
Oceanside, California, 92056, United States
Pacific Clinical Research Medical Group
Orange, California, 92868, United States
SMRI
Sherman Oaks, California, 91403, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Florida Research Center
Maitland, Florida, 32751, United States
University of Miami, Miller School
Miami, Florida, 33136, United States
Miami Research
Miami, Florida, 33143, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Comprehensive NeuroScience Inc.
Atlanta, Georgia, 30328, United States
Hawaii Clinical Research Center
Honolulu, Hawaii, 86813, United States
Psychiatric Medicine Associates
Skokie, Illinois, 60076, United States
Goldpoint Clinical Research
Indianapolis, Indiana, 46260, United States
CRI Worldwide
Willingboro, New Jersey, 08054, United States
Medical & Behavioral Health Research
New York, New York, 10023, United States
Montefiore Medical Center; Anxiety & Depression Clinic; Dept. of Psychiatry
The Bronx, New York, 10467, United States
New Hope Clinical Research
Hickory, North Carolina, 28601, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Harry Croft and Associates
San Antonio, Texas, 78229, United States
University of Texas Health Science Center
San Antonio, Texas, 78229, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Department of Psychiatry, University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Related Publications (2)
Goldberg JF, Siu C, Mao Y, Tsai J, Pikalov A, Calabrese JR, Loebel A. Major depressive disorder with mixed features and treatment response to lurasidone: A symptom network model. J Affect Disord. 2020 Dec 1;277:1045-1054. doi: 10.1016/j.jad.2020.08.048. Epub 2020 Aug 26.
PMID: 33065813DERIVEDSuppes T, Silva R, Cucchiaro J, Mao Y, Targum S, Streicher C, Pikalov A, Loebel A. Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features: A Randomized, Double-Blind, Placebo-Controlled Study. Am J Psychiatry. 2016 Apr 1;173(4):400-7. doi: 10.1176/appi.ajp.2015.15060770. Epub 2015 Nov 10.
PMID: 26552942DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2011
First Posted
August 25, 2011
Study Start
January 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 13, 2012
Record last verified: 2012-12