Major Depressive Disorder With Mixed Features - Extension (RESOLVE3)

March 10, 2016 updated by: Sunovion

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35226
        • Birmingham Psychiatry Pharmaceutical Studies, Inc
    • California
      • Escondido, California, United States, 92025
        • Synergy Clinical Research Center
      • Garden Grove, California, United States, 92845
        • Collaborative Neuro Science Network, Inc.
      • Palo Alto, California, United States, 94304
        • Stanford -VA Palo Alto Health Care System
      • San Diego, California, United States, 92123
        • Artemis Institute for Clinical Research
    • Florida
      • Sarasota, Florida, United States, 34201
        • Florida Clinical Research Center, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • St. Charles Psychiatric Associates/Midwest Research Group
    • New York
      • New York, New York, United States, 10003
        • Village Clinical Research Inc.
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
      • Staten Island, New York, United States, 10305
        • Behavioral Medical Research Of Staten Island
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Psychiatry and Behavioral Sciences, Duke
    • Ohio
      • Dayton, Ohio, United States, 45408
        • Midwest Clinical Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • CRI Worldwide - Kirkbride
    • Texas
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, LP
      • Dallas, Texas, United States, 75390-8849
        • Dept. of Psychiatry, UT Southwestern Medical Center
      • Wichita Falls, Texas, United States, 76309
        • Grayline Clinical Drug Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lurasidone 20, 40, 60 mg
Lurasidone 20, 40, or 60 mg/day flexibly dosed
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
Other Names:
  • Latuda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)
Time Frame: 12 Weeks
Percentage of subjects with treatment emergent adverse events (TEAEs)
12 Weeks
Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame: 12 Weeks
Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)
12 Weeks
Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)
Time Frame: 12 Weeks
Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores
Time Frame: Baseline to12 Weeks
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
Change From Baseline to Week 12 (LOCF) in CGI-S Score
Time Frame: baseline to week 12
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
Change From Baseline to Week 12 (LOCF) in the YMRS Total Score
Time Frame: Baseline to week 12
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
Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score
Time Frame: Baseline to week 12
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
Change From Baseline to Week 12 (LOCF) in the SDS Total Score
Time Frame: Baseline to week 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 24, 2011

First Posted (Estimate)

August 25, 2011

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1050306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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