A Phase III Study of SM-13496 in Patients with Bipolar I Depression.

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222269

Enrollment

501

Registered

2013-10-30

Start date

2013-10-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with major depressive episodes associated with bipolar I disorder.

Interventions

investigational material(s) Generic name etc : SM-13496 (lurasidone HCl) INN of investigational material : Lurasidone Therapeutic category code : 117 Psychotropic agents Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study. -Outpatients aged 18 through 74 years at the time of consent -Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (more than 4 weeks and less than 12 months) without psychotic features etc.

Exclusion criteria

Exclusion criteria: -Patients with imminent risk of suicide or injury to self, others, or property. -Patients who had been hospitalized because of a manic or mixed episode within 60 days prior to screening. -Patients who are otherwise considered ineligible for the study by the investigator. etc.

Design outcomes

Primary

Measure	Time frame
Montgomery-Asberg Depression Rating Scale (MADRS) total score Change from baseline in MADRS total score	—

Secondary

Measure	Time frame
CGI-BP-S (depression) score, etc. Change from baseline in the CGI-BP-S (depression) score, etc	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026