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

Phase 3TerminatedNCT04383691

Sumitomo Pharma (Suzhou) Co., Ltd.124 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

124

Conditions

Bipolar I Depression

Interventions

Lurasidone HClDRUG

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.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Locations (26)

Beijing Anding Hospital capital medical university

Outcomes

Primary Outcomes

Change from baseline in the MADRS total score at Week 6

Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.

Time frame: Baseline/ week 6

Secondary Outcomes

Change from baseline in the CGI-BP-S (depression) score at Week 6

Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression. The CGI depression score ranges from a minimum of 1 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.

Time frame: Baseline/ week 6

Data from ClinicalTrials.gov

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