Major Depressive Disorder With Mixed Features - Extension
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01423253 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lurasidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) |
66.7 | — |
| PRIMARY Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs) |
— | — |
| PRIMARY Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) |
4.2 | — |
| SECONDARY Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores |
-5.9 | — |
| SECONDARY Change From Baseline to Week 12 (LOCF) in CGI-S Score |
-0.47 | — |
| SECONDARY Change From Baseline to Week 12 (LOCF) in the YMRS Total Score |
-1.5 | — |
| SECONDARY Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score |
-1.5 | — |
| SECONDARY Change From Baseline to Week 12 (LOCF) in the SDS Total Score |
-3.6 | — |
Summary
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.
Data sourced from ClinicalTrials.gov (NCT01423253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.