drugset / Trial / NCT01284517
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
RandomizedParallel-groupTriple-blindTreatment
Summary
Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.
Timeline
- Start
- 2010-11
- Primary completion
- 2012-08
- Completion
- 2012-08
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Lurasidone 20-120 mg Flexible Dose+Li/VPA vs Placebo + Li/VPA; p = 0.176; Mean Difference (Final Values) -1.5; Mixed Models Analysis NCT01284517 ↗
paper non-significant improvement at week 6 vs. placebo for the MADRS total score (-11.8 vs-10.4; P=0.176) PMID 27089521 ↗
paper but not at the primary week 6 endpoint. PMID 27089521 ↗
Publications
- Hopkins SC, Tomioka S, Szabo ST, Koblan KS. A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression. Contemp Clin Trials. 2024 Oct;145:107644. doi: 10.1016/j.cct.2024.107644. Epub 2024 Aug 3.
- Suppes T, Kroger H, Pikalov A, Loebel A. Lurasidone adjunctive with lithium or valproate for bipolar depression: A placebo-controlled trial utilizing prospective and retrospective enrolment cohorts. J Psychiatr Res. 2016 Jul;78:86-93. doi: 10.1016/j.jpsychires.2016.03.012. Epub 2016 Mar 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lurasidone | Small molecule | 20 mg | Oral |
| Subject | Lurasidone | Small molecule | 120 mg | Oral |