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A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression

NCT04383691 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2023-01-17

No results posted yet for this study

Summary

The study evaluates the efficacy and safety of lurasidone compared with placebo in treating Bipolar I Depression.

Conditions

  • Bipolar I Depression

Interventions

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.

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    collaborator INDUSTRY

  • Sumitomo Pharma (Suzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Gang Wang, Doctor · Beijing Anding Hospital capital medical university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-11
Primary Completion
2022-12-23
Completion
2022-12-23

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04383691 on ClinicalTrials.gov