Major Depressive Disorder With Mixed Features - Extension

Sumitomo Pharma America, Inc.48 enrolled

Overview

Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features over time.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder

Interventions

LurasidoneDRUG

Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator. Subject has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study D1050305 (NCT#01423240). Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator. Exclusion Criteria: Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at baseline (Day 43 in Study D1050304 or D1050305). Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.

Locations (17)

Birmingham Psychiatry Pharmaceutical Studies, Inc

Birmingham, Alabama, United States

Synergy Clinical Research Center

Escondido, California, United States

Outcomes

Primary Outcomes

Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)

Percentage of subjects with treatment emergent adverse events (TEAEs)

Time frame: 12 Weeks

Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)

Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)

Time frame: 12 Weeks

Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)

Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)

Time frame: 12 Weeks

Secondary Outcomes

Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores

Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject's level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity.

Time frame: Baseline to12 Weeks

Change From Baseline to Week 12 (LOCF) in CGI-S Score

The Clinical Global Impression - Severity of illness (CGI-S) score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.

Time frame: baseline to week 12

Change From Baseline to Week 12 (LOCF) in the YMRS Total Score

The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.