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Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose (RESOLVE 1)

Primary Purpose

Major Depressive Disorder With Mixed Features

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lurasidone
Placebo
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 With Mixed Features 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 is 18 to 75 years of age, inclusive.
  • Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]).

  • Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304):

    • Elevated, expansive mood
    • Inflated self-esteem or grandiosity
    • More talkative than usual or pressure to keep talking
    • Flight of ideas or subjective experience that thoughts are racing
    • Increase in energy or goal-directed activity (either socially, at work or school, or sexually)
    • Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
    • Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia)

Exclusion Criteria:

  • Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening.
  • Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.
  • Subject has attempted suicide within the past 3 months.
  • Subject has a lifetime history of any bipolar I manic or mixed manic episode.
  • Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.

Sites / Locations

  • Birmingham Psychiatry Pharmaceutical Studies, Inc.
  • Synergy Clinical Research Center
  • Collaborative Neuroscience Network Inc.
  • Stanford -VA Palo Alto Health Care System
  • Clinical Innovations Inc.
  • 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
  • Social Psychiatric Research Inst. (SPRI) Clinical Trials
  • 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
  • Municipal Healthcare Institution"City Clinical Hospital #2, n.a. V.I. Razumovsky" of Healthcare Committee of Administration of Municipal Entity "City of Saratov"
  • State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia,
  • Saint Nicholas Psychiatric Hospital.
  • City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit)
  • Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva"
  • Limited Liability Company "Research-And-Educational Centre of Psychotherapy "Podderzhka"
  • Institute of Mental Health
  • Psychiatric Clinic, Clinical Hospital Center"Dr. Dragisa Misovic-Dedinje"
  • Health Centre Cacak Department of Psychiatry
  • Clinical Center Nis, Psychiatric Clinic
  • Clinical Center Kragujevac, Psychiatric Clinic
  • Clinic for Mental Health, Clinical Center Nis
  • Special Hospital for Psychiatric Diseases "Sveti Vracevi"
  • Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"
  • General Hospital "Djordje Joanovic" Psychiatric Dept.
  • Dnipropetrovsk Regional Clinical Hospital named Mechnikov
  • State Institution "Institute of Neurology, Psychiatry and Narcology NAMS of Ukraine", Dep. of Clinical, Social and Child Psychiatry
  • Communal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association "Psychiatric Dept. #10 and Psychiatric Dept. #2
  • "Lugansk State Medical University"Chair of Psychiatry, Narcology and Medical Psychology; Lugansk Regional Clinical Psychoneurological Hospital, Dispensary Dept. for adults
  • Municipal Institution "Lviv Regional State Clinical Psychiatric Hospital, Department #20
  • Odesa Regional Psychoneurological Dispensary, Outpatient Dept.
  • Vinnytsya National Medical University n.a. M.I. Pyrogov, Dept. of Psychiatry and Narcology, Vinnytsya Regional Psychoneurological Hospital n.a. O.I. Yushchenko, Dept. no. 14, Dept. no 15
  • MAC Clinical Research Limited
  • MAC Clinical Research Limited

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lurasidone

Placebo

Arm Description

Lurasidone 20, 40 or 60 mg

Placebo

Outcomes

Primary Outcome Measures

Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores
The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.

Secondary Outcome Measures

Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score
The 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.
Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score
The YMRS is an 11-item clinician-rated 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 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score
The 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).
Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score
The 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.
Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).
Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)

Full Information

First Posted
August 17, 2011
Last Updated
July 13, 2016
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01421134
Brief Title
Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
Acronym
RESOLVE 1
Official Title
A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder With Mixed Features
Keywords
depression, Lurasidone, Latuda

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lurasidone
Arm Type
Experimental
Arm Description
Lurasidone 20, 40 or 60 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Lurasidone
Other Intervention Name(s)
Latuda
Intervention Description
20, 40, 60 mg, flexible dose, once daily PM 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores
Description
The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
Time Frame
Baseline to Week 6
Secondary Outcome Measure Information:
Title
Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score
Description
The 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 6
Title
Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score
Description
The YMRS is an 11-item clinician-rated 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 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Time Frame
Baseline to Week 6
Title
Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score
Description
The 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 6
Title
Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score
Description
The 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 6
Title
Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).
Time Frame
Baseline to Week 6
Title
Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)
Time Frame
Baseline to Week 6

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 is 18 to 75 years of age, inclusive. Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]). Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304): Elevated, expansive mood Inflated self-esteem or grandiosity More talkative than usual or pressure to keep talking Flight of ideas or subjective experience that thoughts are racing Increase in energy or goal-directed activity (either socially, at work or school, or sexually) Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments) Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia) Exclusion Criteria: Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening. Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit. Subject has attempted suicide within the past 3 months. Subject has a lifetime history of any bipolar I manic or mixed manic episode. Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.
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 Neuroscience 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
Clinical Innovations Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92506
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
Social Psychiatric Research Inst. (SPRI) Clinical Trials
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
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
45417
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
Facility Name
Municipal Healthcare Institution"City Clinical Hospital #2, n.a. V.I. Razumovsky" of Healthcare Committee of Administration of Municipal Entity "City of Saratov"
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia,
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Facility Name
Saint Nicholas Psychiatric Hospital.
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit)
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva"
City
St. Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Facility Name
Limited Liability Company "Research-And-Educational Centre of Psychotherapy "Podderzhka"
City
Stavropol
ZIP/Postal Code
355000
Country
Russian Federation
Facility Name
Institute of Mental Health
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Psychiatric Clinic, Clinical Hospital Center"Dr. Dragisa Misovic-Dedinje"
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Health Centre Cacak Department of Psychiatry
City
Cacak
ZIP/Postal Code
32000
Country
Serbia
Facility Name
Clinical Center Nis, Psychiatric Clinic
City
Gornja Toponica
ZIP/Postal Code
18201
Country
Serbia
Facility Name
Clinical Center Kragujevac, Psychiatric Clinic
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinic for Mental Health, Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Special Hospital for Psychiatric Diseases "Sveti Vracevi"
City
Vojvodina
ZIP/Postal Code
23330
Country
Serbia
Facility Name
Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"
City
Vrsac
ZIP/Postal Code
26300
Country
Serbia
Facility Name
General Hospital "Djordje Joanovic" Psychiatric Dept.
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
State Institution "Institute of Neurology, Psychiatry and Narcology NAMS of Ukraine", Dep. of Clinical, Social and Child Psychiatry
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Communal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association "Psychiatric Dept. #10 and Psychiatric Dept. #2
City
Kyiv
ZIP/Postal Code
08631
Country
Ukraine
Facility Name
"Lugansk State Medical University"Chair of Psychiatry, Narcology and Medical Psychology; Lugansk Regional Clinical Psychoneurological Hospital, Dispensary Dept. for adults
City
Lugansk
ZIP/Postal Code
91045
Country
Ukraine
Facility Name
Municipal Institution "Lviv Regional State Clinical Psychiatric Hospital, Department #20
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Odesa Regional Psychoneurological Dispensary, Outpatient Dept.
City
Odesa
ZIP/Postal Code
65014
Country
Ukraine
Facility Name
Vinnytsya National Medical University n.a. M.I. Pyrogov, Dept. of Psychiatry and Narcology, Vinnytsya Regional Psychoneurological Hospital n.a. O.I. Yushchenko, Dept. no. 14, Dept. no 15
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
MAC Clinical Research Limited
City
Cannock
ZIP/Postal Code
WS11 0BN
Country
United Kingdom
Facility Name
MAC Clinical Research Limited
City
Manchester
ZIP/Postal Code
M32 0UT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30086213
Citation
Clayton AH, Tsai J, Mao Y, Pikalov A, Loebel A. Effect of Lurasidone on Sexual Function in Major Depressive Disorder Patients With Subthreshold Hypomanic Symptoms (Mixed Features): Results From a Placebo-Controlled Trial. J Clin Psychiatry. 2018 Aug 7;79(5):18m12132. doi: 10.4088/JCP.18m12132.
Results Reference
derived
PubMed Identifier
29943445
Citation
Targum SD, Pendergrass JC, Lee S, Loebel A. Ratings surveillance and reliability in a study of major depressive disorder with subthreshold hypomania (mixed features). Int J Methods Psychiatr Res. 2018 Dec;27(4):e1729. doi: 10.1002/mpr.1729. Epub 2018 Jun 26.
Results Reference
derived
PubMed Identifier
26908089
Citation
Targum SD, Suppes T, Pendergrass JC, Lee S, Silva R, Cucchiaro J, Loebel A. Major depressive disorder with subthreshold hypomania (mixed features): Clinical characteristics of patients entered in a multiregional, placebo-controlled study. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jul 4;68:9-14. doi: 10.1016/j.pnpbp.2016.02.007. Epub 2016 Feb 22.
Results Reference
derived

Learn more about this trial

Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose

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