A Phase 2 interventional study of Lurasidone 80mg tablet in Schizophrenia, sponsored by Sumitomo Pharma America, Inc.. Completed at 21 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2014-04-17.
Sponsored by Sumitomo Pharma America, Inc. · Phase 2, Interventional, and Treatment
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia
Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Scale [BAS], and Simpson-Angus Rating Scale [SAS]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 61 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Lurasidone 80mg oral tablet taken once a day
Drug: Lurasidone 80mg tablet
Also known as: Lurasidone
Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study
Time frame: 1 year
| Milestone | Lurasidone 80 mg |
|---|---|
| Started | 61 |
| Completed | 7 |
| Not completed | 54 |
| participants | Lurasidone 80 mg |
|---|---|
| Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study | 59 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lurasidone 80 mg | — | 12/59 (20.3%) | 18/59 (30.5%) |
| Event | Lurasidone 80 mg |
|---|---|
| SchizophreniaPsychiatric disorders | 8/59 |
| Pericardial EffusionCardiac disorders | 1/59 |
| OrchitisInfections and infestations | 1/59 |
| PneumoniaInfections and infestations | 1/59 |
| SepsisInfections and infestations | 1/59 |
| Cerebrovascular AccidentNervous system disorders | 1/59 |
| Self Injurious BehaviorPsychiatric disorders | 1/59 |
| ProstatitisReproductive system and breast disorders | 1/59 |
| Pulmonary MassRespiratory, thoracic and mediastinal disorders | 1/59 |
| Event | Lurasidone 80 mg |
|---|---|
| NauseaGastrointestinal disorders | 4/59 |
| BronchitisInfections and infestations | 4/59 |
| Weight IncreasedInvestigations | 4/59 |
| SedationNervous system disorders | 4/59 |
| VomitingGastrointestinal disorders | 3/59 |
| NasopharyngitisInfections and infestations | 3/59 |
| Upper Respiratory Tract InfectionInfections and infestations | 3/59 |
| Weight DecreasedInvestigations | 3/59 |
| Age, Continuous(years) | Lurasidone 80 mg |
|---|---|
| Mean | 41.3 ± 11.05 |
| Sex: Female, Male(Participants) | Lurasidone 80 mg |
|---|---|
| Female | 15 |
| Male | 44 |
| Region of Enrollment(participants) | Lurasidone 80 mg |
|---|---|
| United States | 59 |
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Sumitomo Pharma America, Inc.