Phase 3
Completed N=505
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
Source: ClinicalTrials.gov NCT00868699 ↗Enrolled (actual)
505
Serious AEs
1.8%
Results posted
Jul 2013
Primary outcomePrimary: Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) — -10.7; -15.4; -15.4 units on a scale — p=<0.001
Summary
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) |
-10.7; -15.4; -15.4 | <0.001 sig |
| SECONDARY Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) |
-1.14; -1.71; -1.83 | <0.001 sig |
| SECONDARY Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score |
-6.3; -9.8; -9.5 | 0.003 sig |
Eligibility Criteria
Inclusion Criteria
- Subject is diagnosed with bipolar I disorder, most resent episode depressed
- Subject must have a lifetime history of at least one bipolar manic or mixed episode
Exclusion Criteria
- History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
- Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
- Imminent risk of suicide or injury to self, others, or property
Data sourced from ClinicalTrials.gov (NCT00868699). 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.