Major Depressive Disorder With Mixed Features - Extension

Major Depressive Disorder Clinical Trial

— RESOLVE3  

Official title:

A 12-Week, Open-Label Extension Study For the Treatment of Major Depressive Disorder With Mixed Features

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423253
• Other study ID #: D1050306
• Status: Completed
• Phase: Phase 3
• First received: August 23, 2011
• Last updated: March 10, 2016
• Start date: September 2011
• Est. completion date: October 2013

Study information

• Verified date: March 2016
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Lurasidone
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

Locations

Country	Name	City	State
United States	Birmingham Psychiatry Pharmaceutical Studies, Inc	Birmingham	Alabama
United States	Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders	Boston	Massachusetts
United States	Dept. of Psychiatry, UT Southwestern Medical Center	Dallas	Texas
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Psychiatry and Behavioral Sciences, Duke	Durham	North Carolina
United States	Synergy Clinical Research Center	Escondido	California
United States	Collaborative Neuro Science Network, Inc.	Garden Grove	California
United States	Village Clinical Research Inc.	New York	New York
United States	Stanford -VA Palo Alto Health Care System	Palo Alto	California
United States	CRI Worldwide - Kirkbride	Philadelphia	Pennsylvania
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Florida Clinical Research Center, LLC	Sarasota	Florida
United States	St. Charles Psychiatric Associates/Midwest Research Group	St. Charles	Missouri
United States	Behavioral Medical Research of Staten Island	Staten Island	New York
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)	Percentage of subjects with treatment emergent adverse events (TEAEs)	12 Weeks
Primary	Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)	Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)	12 Weeks
Primary	Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)	Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)	12 Weeks
Secondary	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.	Baseline to12 Weeks
Secondary	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.	baseline to week 12
Secondary	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.	Baseline to week 12
Secondary	Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score	The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.	Baseline to week 12
Secondary	Change From Baseline to Week 12 (LOCF) in the SDS Total Score	The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).	Baseline to week 12