Phase 3
Completed N=965
Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
Source: ClinicalTrials.gov NCT01358357 ↗Enrolled (actual)
965
Serious AEs
4.5%
Results posted
Jul 2016
Primary outcomePrimary: Time to Recurrence of Mood Event During the Double Blind Treatment Phase — NA; 207 Days — p=<0.078
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Recurrence of Mood Event During the Double Blind Treatment Phase |
NA; 207 | <0.078 |
| SECONDARY Time to All-cause Discontinuation |
225; 207 | <0.034 sig |
| SECONDARY Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode |
NA; NA | 0.113 |
| SECONDARY Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode |
16.7; 21.6 | — |
| SECONDARY Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score |
0.40; 0.49 | 0.406 |
| SECONDARY Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score |
0.10; 0.21 | 0.162 |
| SECONDARY Change From Double-blind Baseline to Week 28 (LOCF) in CGI+-BP-S Depression Score |
0.35; 0.42 | 0.496 |
| SECONDARY Change From Double-blind Baseline to Week 28 (LOCF) in YMRS Total Score |
1.0; 1.8 | 0.128 |
| SECONDARY Change From Double-blind Baseline to Week 28 (LOCF) in MADRS Total Score |
3.0; 3.5 | 0.485 |
| SECONDARY Change Fro Double-blind Baseline to Week 28 (LOCF) in QIDS-SR(16) Total Score |
0.9; 1.1 | 0.582 |
| SECONDARY Change From Double-blind Baseline to Week 28 (LOF) in PANSS Positive Symptom (PANNS-P) Subscale Score |
0.2; 0.3 | 0.420 |
| SECONDARY Change From Double-blind Baseline to Week 28 (LOCF) in SDS Total Score |
0.4; 0.6 | 0.788 |
| SECONDARY Change From Double-blind Baseline to Week 28 (LOCF) in PIRS-2 Total Score |
0.4; 0.5 | 0.380 |
| SECONDARY Change From Double-blind Baseline to Week 28 (LOCF) in Q-LES-Q-SF Percent Maximum Possible Score |
-1.70; -2.07 | 0.772 |
Eligibility Criteria
Inclusion Criteria
Open-label Phase
- 18 years of age or older
- Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) diagnosis of bipolar I disorder
•≥ 1 manic, mixed manic, or depressed episode in past 2 years
- YMRS or MADRS total score ≥ 14 if on lithium or divalproex; ≥ 18 if not on lithium or divalproex
Double-blind Phase
Inclusion Criteria
- Subjects must achieve consistent clinical stability, defined as total scores ≤ 12 on the YMRS and MADRS over at least 12 weeks, with the allowance of two excursions (YMRS and/or MADRS total scores up to 13 or 14, respectively) except during the last 4 weeks before randomization
Exclusion Criteria
Open Label Phase
- Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the primary focus of treatment within 3 months of screening
- Subjects for whom diagnostic agreement between the Investigator and United BioSource Corporation (Boston) (UBC) cannot be reached
- Ultra-fast rapid cycling (defined as ≥ 8 mood episodes over the previous 12-month period)
- Subjects who test positive for drugs of abuse at screening. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study
- Unstable/inadequately treated medical illness
- The subjects answers "yes" to "Suicidal Ideation" items 4 or 5 on the C-SSRS (at time of evaluation)
Double Blind Phase
- Subjects who in the Investigator's judgment have not been compliant with study medication during the stabilization phase
- Subjects who have not stabilized during the open-label phase (within 20 weeks)
- Subjects who test positive for drugs of abuse at double-blind phase baseline. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study
Data sourced from ClinicalTrials.gov (NCT01358357). 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.