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Major Depressive Disorder With Mixed Features - Extension (RESOLVE3)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lurasidone
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Lurasidone, Latuda

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham Psychiatry Pharmaceutical Studies, Inc
  • Synergy Clinical Research Center
  • Collaborative Neuro Science Network, Inc.
  • Stanford -VA Palo Alto Health Care System
  • Artemis Institute for Clinical Research
  • Florida Clinical Research Center, LLC
  • Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders
  • St. Charles Psychiatric Associates/Midwest Research Group
  • Village Clinical Research Inc.
  • Finger Lakes Clinical Research
  • Behavioral Medical Research of Staten Island
  • Psychiatry and Behavioral Sciences, Duke
  • Midwest Clinical Research Center
  • CRI Worldwide - Kirkbride
  • FutureSearch Trials of Dallas, LP
  • Dept. of Psychiatry, UT Southwestern Medical Center
  • Grayline Clinical Drug Trials

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lurasidone 20, 40, 60 mg

Arm Description

Lurasidone 20, 40, or 60 mg/day flexibly dosed

Outcomes

Primary Outcome Measures

Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)
Percentage of subjects with treatment emergent adverse events (TEAEs)
Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)
Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)
Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)
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
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
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
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
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
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).

Full Information

First Posted
August 23, 2011
Last Updated
March 10, 2016
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01423253
Brief Title
Major Depressive Disorder With Mixed Features - Extension
Acronym
RESOLVE3
Official Title
A 12-Week, Open-Label Extension Study For the Treatment of Major Depressive Disorder With Mixed Features
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Lurasidone, Latuda

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lurasidone 20, 40, 60 mg
Arm Type
Experimental
Arm Description
Lurasidone 20, 40, or 60 mg/day flexibly dosed
Intervention Type
Drug
Intervention Name(s)
Lurasidone
Other Intervention Name(s)
Latuda
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)
Description
Percentage of subjects with treatment emergent adverse events (TEAEs)
Time Frame
12 Weeks
Title
Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)
Description
Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame
12 Weeks
Title
Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)
Description
Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores
Description
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
Title
Change From Baseline to Week 12 (LOCF) in CGI-S Score
Description
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
Title
Change From Baseline to Week 12 (LOCF) in the YMRS Total Score
Description
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.
Time Frame
Baseline to week 12
Title
Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score
Description
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.
Time Frame
Baseline to week 12
Title
Change From Baseline to Week 12 (LOCF) in the SDS Total Score
Description
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).
Time Frame
Baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, MD
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Psychiatry Pharmaceutical Studies, Inc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35226
Country
United States
Facility Name
Synergy Clinical Research Center
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Collaborative Neuro Science Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Stanford -VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
St. Charles Psychiatric Associates/Midwest Research Group
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Village Clinical Research Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Behavioral Medical Research of Staten Island
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Psychiatry and Behavioral Sciences, Duke
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
CRI Worldwide - Kirkbride
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
FutureSearch Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Dept. of Psychiatry, UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8849
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Major Depressive Disorder With Mixed Features - Extension

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