Phase 3
Completed N=525
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
Source: ClinicalTrials.gov NCT01986101 ↗Enrolled (actual)
525
Serious AEs
2.1%
Results posted
Jul 2019
Primary outcomePrimary: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 — -10.6; -13.6; -12.6 units on a scale — p=0.007
◆ Published Evidence
Established
47citations · ~8 / year
Double-blind, placebo-controlled study of lurasidone monotherapy for the treatment of bipolar I depression.
Summary
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.
Linked Publications (4)
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Double-blind, placebo-controlled study of lurasidone monotherapy for the treatment of bipolar I depression.
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Lurasidone, olanzapine, and quetiapine extended-release for bipolar depression: A systematic review and network meta-analysis of phase 3 trials in Japan.
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A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression.
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A diagnostic test to examine early improvement as a predictor of later response to lurasidone in bipolar depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 |
-10.6; -13.6; -12.6 | 0.007 sig |
| SECONDARY Change From Baseline in the CGI-BP-S (Depression) Score at Week 6 |
-1.11; -1.51; -1.41 | 0.002 sig |
| SECONDARY Change From Baseline in the SDS Total Score at Week 6 (LOCF) |
-5.7; -7.6; -6.8 | 0.037 sig |
| SECONDARY Change From Baseline in the YMRS Total Score at Week 6 |
-0.51; -0.98; -0.99 | 0.076 |
| SECONDARY Change From Baseline in the HAM-A Total Score at Week 6 (LOCF) |
-5.7; -7.4; -6.4 | 0.016 sig |
Eligibility 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 (≥ 4 weeks and less than 12 months) without psychotic features.
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.
Data sourced from ClinicalTrials.gov (NCT01986101) and the linked publication. 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.