Clinical trial NCT01423253: Major Depressive Disorder With Mixed Features - Extension
Official title: A 12-Week, Open-Label Extension Study For the Treatment of Major Depressive Disorder With Mixed Features
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depression
Lurasidone
Latuda
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)
timeFrame: 12 Weeks
measure: Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: 12 Weeks
measure: Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores
timeFrame: Baseline to12 Weeks
measure: Change From Baseline to Week 12 (LOCF) in CGI-S Score
timeFrame: baseline to week 12
measure: Change From Baseline to Week 12 (LOCF) in the YMRS Total Score
timeFrame: Baseline to week 12
measure: Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score
timeFrame: Baseline to week 12
measure: Change From Baseline to Week 12 (LOCF) in the SDS Total Score
timeFrame: Baseline to week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharmaceutical Studies, Inc
state: Alabama
city: Escondido
country: United States
facility: Synergy Clinical Research Center
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuro Science Network, Inc.
state: California
city: Palo Alto
country: United States
facility: Stanford -VA Palo Alto Health Care System
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Sarasota
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders
state: Massachusetts
city: St. Charles
country: United States
facility: St. Charles Psychiatric Associates/Midwest Research Group
state: Missouri
city: New York
country: United States
facility: Village Clinical Research Inc.
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research of Staten Island
state: New York
city: Durham
country: United States
facility: Psychiatry and Behavioral Sciences, Duke
state: North Carolina
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Philadelphia
country: United States
facility: CRI Worldwide - Kirkbride
state: Pennsylvania
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Dallas
country: United States
facility: Dept. of Psychiatry, UT Southwestern Medical Center
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References: