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

Sumitomo Pharma

Status and phase: Terminated; Phase 3

Conditions: Bipolar I Depression

Treatments: Drug: Placebo; Drug: Lurasidone HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT04383691

D1071301

Details and patient eligibility

About

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

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Patients who have provided written voluntary consent in person after receiving and understanding adequate explanation about the study, including the objectives, content, expected therapeutic and pharmacological effects, and risks.
2. Outpatients who are aged 18 through 65 years at time of informed consent.
3. Patients with bipolar I disorder, most recent episode depressed, without rapid cycling disease course ( no less than 4 episodes of mood disturbance in the 12 months prior to screening), and without psychotic features (diagnosed by DSM-5 criteria).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups, including a placebo group

Lurasidone

Experimental group

Description:

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.

Treatment:

Drug: Lurasidone HCl

Placebo

Placebo Comparator group

Description:

Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo.

Treatment:

Drug: Placebo