search
Back to results

Major Depressive Disorder With Mixed Features (RESOLVE2)

Primary Purpose

Major Depressive Disorder

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lurasidone 20 mg
Lurasidone 60 mg
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 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 D1050305):

  • 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) Subject has a rater-administered Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and both a rater-administered and self-rated (administered by computer) MADRS total score ≥ 26 at baseline.

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 Research Group
  • Sun Valley Behavioral Medical
  • Synergy Clinical Research Center
  • Excell Research
  • Pacific Clinical Research Medical Group
  • SMRI
  • Sarkis Clinical Trials
  • Florida Research Center
  • University of Miami, Miller School
  • Miami Research
  • Atlanta Center for Medical Research
  • Comprehensive NeuroScience Inc.
  • Hawaii Clinical Research Center
  • Psychiatric Medicine Associates
  • Goldpoint Clinical Research
  • CRI Worldwide
  • Montefiore Medical Center; Anxiety & Depression Clinic; Dept. of Psychiatry
  • Medical & Behavioral Health Research
  • New Hope Clinical Research
  • Sooner Clinical Research
  • Lehigh Center for Clinical Research
  • Suburban Research Associates
  • Harry Croft and Associates
  • University of Texas Health Science Center
  • Grayline Clinical Drug Trials
  • Department of Psychiatry, University of Utah Health Sciences Center
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Lurasidone 20 mg

Lurasidone 60 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

MADRS
Mean change from baseline in MADRS total score after 6 weeks of treatment

Secondary Outcome Measures

CGI-S
Global severity assessed by the CGI-S score (depression)

Full Information

First Posted
August 23, 2011
Last Updated
December 11, 2012
Sponsor
Sumitomo Pharma America, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01423240
Brief Title
Major Depressive Disorder With Mixed Features
Acronym
RESOLVE2
Official Title
A Randomized, 6-week, Double-blind, Placebo-controlled, Fixed-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
December 2012
Overall Recruitment Status
Withdrawn
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

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
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
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lurasidone 20 mg
Arm Type
Experimental
Arm Title
Lurasidone 60 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lurasidone 20 mg
Other Intervention Name(s)
Latuda
Intervention Description
Lurasidone 20 mg once daily orally in the evening
Intervention Type
Drug
Intervention Name(s)
Lurasidone 60 mg
Other Intervention Name(s)
Latuda
Intervention Description
Lurasidone 60 mg once daily orally in the evening
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily orally in the evening
Primary Outcome Measure Information:
Title
MADRS
Description
Mean change from baseline in MADRS total score after 6 weeks of treatment
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
CGI-S
Description
Global severity assessed by the CGI-S score (depression)
Time Frame
6 weeks

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 D1050305): 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) Subject has a rater-administered Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and both a rater-administered and self-rated (administered by computer) MADRS total score ≥ 26 at baseline. 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 Research Group
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Sun Valley Behavioral Medical
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Synergy Clinical Research Center
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
SMRI
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Florida Research Center
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
University of Miami, Miller School
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Miami Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Comprehensive NeuroScience Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Hawaii Clinical Research Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
86813
Country
United States
Facility Name
Psychiatric Medicine Associates
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Goldpoint Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
CRI Worldwide
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
Montefiore Medical Center; Anxiety & Depression Clinic; Dept. of Psychiatry
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Medical & Behavioral Health Research
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
New Hope Clinical Research
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Lehigh Center for Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Harry Croft and Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Department of Psychiatry, University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33065813
Citation
Goldberg JF, Siu C, Mao Y, Tsai J, Pikalov A, Calabrese JR, Loebel A. Major depressive disorder with mixed features and treatment response to lurasidone: A symptom network model. J Affect Disord. 2020 Dec 1;277:1045-1054. doi: 10.1016/j.jad.2020.08.048. Epub 2020 Aug 26.
Results Reference
derived
PubMed Identifier
26552942
Citation
Suppes T, Silva R, Cucchiaro J, Mao Y, Targum S, Streicher C, Pikalov A, Loebel A. Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features: A Randomized, Double-Blind, Placebo-Controlled Study. Am J Psychiatry. 2016 Apr 1;173(4):400-7. doi: 10.1176/appi.ajp.2015.15060770. Epub 2015 Nov 10.
Results Reference
derived

Learn more about this trial

Major Depressive Disorder With Mixed Features

We'll reach out to this number within 24 hrs