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Major Depressive Disorder With Mixed Features - Extension (RESOLVE3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01423253
First received: August 23, 2011
Last updated: March 10, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Major Depressive Disorder
Drug: Lurasidone
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-Week, Open-Label Extension Study For the Treatment of Major Depressive Disorder With Mixed Features

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    Percentage of subjects with treatment emergent adverse events (TEAEs)

  • Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)

  • Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)


Secondary Outcome Measures:
  • Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores [ Time Frame: Baseline to12 Weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to Week 12 (LOCF) in CGI-S Score [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to Week 12 (LOCF) in the YMRS Total Score [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to Week 12 (LOCF) in the SDS Total Score [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
    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).


Enrollment: 48
Study Start Date: September 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Latuda

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423253

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

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01423253     History of Changes
Other Study ID Numbers: D1050306 
Study First Received: August 23, 2011
Results First Received: September 15, 2015
Last Updated: March 10, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Depression
Lurasidone
Latuda

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 28, 2016