Phase 3
N=348
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)
Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT00868452 ↗Enrolled (actual)
348
Serious AEs
1.2%
Results posted
Apr 2013
Primary outcome: Primary: Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) — -17.1; -13.5 units on a scale — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- lurasidone + (lithium or divalproex) (Drug); Placebo + (lithium or divalproex) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Dec 2011
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) |
-17.1; -13.5 | 0.005 sig |
| SECONDARY Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) |
-1.96; -1.51 | 0.003 sig |
| SECONDARY Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score |
-9.5; -7.0 | 0.012 sig |
Summary
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.
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
- Subject must be taking lithium or divalproex at least 28 days prior to screening
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 (NCT00868452). 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.