Phase 3
Completed N=377
This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296
Source: ClinicalTrials.gov NCT01575561 ↗Enrolled (actual)
377
Serious AEs
3.7%
Results posted
Aug 2016
Primary outcomePrimary: Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events — 155; 69; 14; 1 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events |
155; 69; 14; 1; 9 | — |
| SECONDARY Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score |
-1.0 | — |
| SECONDARY Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score |
-0.2 | — |
| SECONDARY Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS) |
-1.0 | — |
| SECONDARY Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS) |
-1.9 | — |
| SECONDARY Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) |
-.31 | — |
| SECONDARY Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score |
-0.13 | — |
| SECONDARY Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale |
-0.27 | — |
| SECONDARY Change From Baseline to Week 12 (LOCF) in the SDS Total Score |
-1.4 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has agreed to participate by providing written informed consent.
- Subject has completed the 28 week Double-blind Phase of Study D1050296 and all required assessments on the final study visit (Week 28, Visit 28); OR
- Subject has experienced a protocol-defined recurrence of any mood event during the Double blind Phase of Study D1050296 and has completed all required assessments on the final study visit; OR
- Subject had at least entered the Open-label Phase of Study D1050296 when the Sponsor stopped the study and has completed all required assessments on the final study visit.
- Subject is judged by the Investigator to be suitable for participation in a 12 week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.
Exclusion Criteria
- Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
- Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at the extension baseline visit (final study visit in Study D1050296).
Data sourced from ClinicalTrials.gov (NCT01575561). 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.