Phase 3
N=211
Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
Major Depressive Disorder With Mixed Features
Bottom Line
View on ClinicalTrials.gov: NCT01421134 ↗Enrolled (actual)
211
Serious AEs
0.5%
Results posted
Oct 2015
Primary outcome: Primary: Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores — -20.5; -13.0 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lurasidone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores |
-20.5; -13.0 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score |
-1.83; -1.18 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score |
-7.0; -4.9 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score |
-11.2; -6.4 | 0.0001 sig |
| SECONDARY Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score |
-9.9; -5.4 | <0.0001 sig |
| SECONDARY Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF). |
64.8; 30.0 | <0.0001 sig |
| SECONDARY Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF) |
49.1; 23.0 | <0.0001 sig |
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.
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 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 D1050304):
- 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)
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01421134). 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.