Phase 3
Completed N=211
Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
Major Depressive Disorder With Mixed Features
Source: ClinicalTrials.gov NCT01421134 ↗
Enrolled (actual)
211
Serious AEs
0.5%
Results posted
Oct 2015
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.