Phase 3 N=505 Randomized Double-blind Treatment

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

Bipolar Depression

Bottom Line

View on ClinicalTrials.gov: NCT00868699 ↗

Enrolled (actual)

505

Serious AEs

1.8%

Results posted

Jul 2013

Primary outcome: 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 units on a scale — p=<0.001

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: Feb 2012

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

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

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

View full record on ClinicalTrials.gov →

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.