Major Depressive Disorder With Mixed Features - Extension
- Registration Number
- NCT01423253
- 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 over time.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lurasidone 20, 40, 60 mg Lurasidone Lurasidone 20, 40, or 60 mg/day flexibly dosed
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) 12 Weeks Percentage of subjects with treatment emergent adverse events (TEAEs)
Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs) 12 Weeks Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)
Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) 12 Weeks Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores Baseline to12 Weeks Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject's level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity.
Change From Baseline to Week 12 (LOCF) in CGI-S Score baseline to week 12 The Clinical Global Impression - Severity of illness (CGI-S) score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
Change From Baseline to Week 12 (LOCF) in the YMRS Total Score Baseline to week 12 The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score Baseline to week 12 The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.
Change From Baseline to Week 12 (LOCF) in the SDS Total Score Baseline to week 12 The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).
Trial Locations
- Locations (17)
St. Charles Psychiatric Associates/Midwest Research Group
🇺🇸St. Charles, Missouri, United States
Village Clinical Research Inc.
🇺🇸New York, New York, United States
Stanford -VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
Florida Clinical Research Center, LLC
🇺🇸Sarasota, Florida, United States
Dept. of Psychiatry, UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Birmingham Psychiatry Pharmaceutical Studies, Inc
🇺🇸Birmingham, Alabama, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders
🇺🇸Boston, Massachusetts, United States
Psychiatry and Behavioral Sciences, Duke
🇺🇸Durham, North Carolina, United States
Synergy Clinical Research Center
🇺🇸Escondido, California, United States
Collaborative Neuro Science Network, Inc.
🇺🇸Garden Grove, California, United States
Behavioral Medical Research of Staten Island
🇺🇸Staten Island, New York, United States
FutureSearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
CRI Worldwide - Kirkbride
🇺🇸Philadelphia, Pennsylvania, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States