Major Depressive Disorder With Mixed Features
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT01423240
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lurasidone 20 mg Lurasidone 20 mg - Lurasidone 60 mg Lurasidone 60 mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method MADRS 6 weeks Mean change from baseline in MADRS total score after 6 weeks of treatment
- Secondary Outcome Measures
Name Time Method CGI-S 6 weeks Global severity assessed by the CGI-S score (depression)
Trial Locations
- Locations (27)
Montefiore Medical Center; Anxiety & Depression Clinic; Dept. of Psychiatry
🇺🇸Bronx, New York, United States
New Hope Clinical Research
🇺🇸Hickory, North Carolina, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Medical & Behavioral Health Research
🇺🇸New York, New York, United States
Hawaii Clinical Research Center
🇺🇸Honolulu, Hawaii, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
Excell Research
🇺🇸Oceanside, California, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Florida Research Center
🇺🇸Maitland, Florida, United States
Pacific Clinical Research Medical Group
🇺🇸Orange, California, United States
SMRI
🇺🇸Sherman Oaks, California, United States
Birmingham Research Group
🇺🇸Birmingham, Alabama, United States
Sun Valley Behavioral Medical
🇺🇸Imperial, California, United States
University of Miami, Miller School
🇺🇸Miami, Florida, United States
Miami Research
🇺🇸Miami, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Comprehensive NeuroScience Inc.
🇺🇸Atlanta, Georgia, United States
Psychiatric Medicine Associates
🇺🇸Skokie, Illinois, United States
Goldpoint Clinical Research
🇺🇸Indianapolis, Indiana, United States
CRI Worldwide
🇺🇸Willingboro, New Jersey, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Harry Croft and Associates
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
Department of Psychiatry, University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States