Phase 3
Completed N=495
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
Source: ClinicalTrials.gov NCT01986114 ↗Enrolled (actual)
495
Serious AEs
4.5%
Results posted
Jul 2019
Primary outcomePrimary: Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) — 352; 169 Participants
◆ Published Evidence
Emerging
10citations · ~2 / year
Lurasidone in the Long-Term Treatment of Bipolar I Depression: A 28-week Open Label Extension Study.
Summary
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.
Linked Publications (2)
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Lurasidone in the Long-Term Treatment of Bipolar I Depression: A 28-week Open Label Extension Study.
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Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) |
352; 169 | — |
| SECONDARY Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score |
-4.4; 1.1 | — |
| SECONDARY Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score. |
-1.0; -2.0 | — |
| SECONDARY Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. |
14; 18 | — |
Eligibility Criteria
Inclusion Criteria
Patients who completed the D1002001 study
・Patients who completed the D1002001 study and who are considered by the investigator to be eligible and without safety concerns.
Patients who did not participate in the D1002001 study
- 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 manic, hypomanic, or mixed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance, but < 8 episodes in the previous 12 months prior to screening).
Exclusion Criteria
- Patients with imminent risk of suicide or injury to self, others, or property.
- Patients who are otherwise considered ineligible for the study by the investigator.
Data sourced from ClinicalTrials.gov (NCT01986114) 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.