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.
Brief Title
Major Depressive Disorder With Mixed Features - Extension
Categories
Completion Date
Completion Date Type
Actual
Conditions
Major Depressive Disorder
Eligibility Criteria
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.
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.
Inclusion Criteria
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.
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.
Gender
All
Gender Based
false
Keywords
Depression
Lurasidone
Latuda
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT01423253
Org Class
Industry
Org Full Name
Sumitomo Pharma America, Inc.
Org Study Id
D1050306
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A 12-Week, Open-Label Extension Study For the Treatment of Major Depressive Disorder With Mixed Features
Primary Outcomes
Outcome Description
Percentage of subjects with treatment emergent adverse events (TEAEs)
Outcome Measure
Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)
Outcome Time Frame
12 Weeks
Outcome Description
Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)
Outcome Measure
Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)
Outcome Time Frame
12 Weeks
Outcome Description
Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)
Outcome Measure
Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)
Outcome Time Frame
12 Weeks
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Baseline to12 Weeks
Outcome Measure
Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores
Outcome Description
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.
Outcome Time Frame
baseline to week 12
Outcome Measure
Change From Baseline to Week 12 (LOCF) in CGI-S Score
Outcome Description
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.
Outcome Time Frame
Baseline to week 12
Outcome Measure
Change From Baseline to Week 12 (LOCF) in the YMRS Total Score
Outcome Description
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.
Outcome Time Frame
Baseline to week 12
Outcome Measure
Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score
Outcome Description
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).
Outcome Time Frame
Baseline to week 12
Outcome Measure
Change From Baseline to Week 12 (LOCF) in the SDS Total Score
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Gregory Asnis
Investigator Email
gasnis@montefiore.org
Investigator Phone