Trials / Terminated
TerminatedNCT04383691
A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression
A Randomized, 6-Week, Multicenter, Double-Blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 124 (actual)
- Sponsor
- Sumitomo Pharma (Suzhou) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The study evaluates the efficacy and safety of lurasidone compared with placebo in treating Bipolar I Depression.
Detailed description
The primary objective is to compare the efficacy of lurasidone (20-120 mg/day) monotherapy with that of placebo in patients with Bipolar I Depression by assessing the change from baseline in the MADRS total score at Week 6.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lurasidone HCl | Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. Flexible dosing of study drug will be permitted beginning on Day 8. |
| DRUG | Placebo | Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo. |
Timeline
- Start date
- 2020-12-11
- Primary completion
- 2022-12-23
- Completion
- 2022-12-23
- First posted
- 2020-05-12
- Last updated
- 2023-01-17
Locations
26 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04383691. Inclusion in this directory is not an endorsement.