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

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ClinicalTrials.gov Identifier: NCT01421134
Recruitment Status : Completed
First Posted : August 22, 2011
Results First Posted : October 9, 2015
Last Update Posted : July 15, 2016
Sponsor:
Information provided by (Responsible Party):
Sunovion

Tracking Information
First Submitted Date  ICMJE August 17, 2011
First Posted Date  ICMJE August 22, 2011
Results First Submitted Date  ICMJE September 10, 2015
Results First Posted Date  ICMJE October 9, 2015
Last Update Posted Date July 15, 2016
Study Start Date  ICMJE September 2011
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores [ Time Frame: Baseline to Week 6 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2011)
MADRS [ Time Frame: 6 weeks ]
Mean change from baseline to the 6-week study endpoint in MADRS score
Change History Complete list of historical versions of study NCT01421134 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
  • Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score [ Time Frame: Baseline to Week 6 ]
    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 [ Time Frame: Baseline to Week 6 ]
    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 [ Time Frame: Baseline to Week 6 ]
    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 [ Time Frame: Baseline to Week 6 ]
    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). [ Time Frame: Baseline to Week 6 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2011)
CGI-S [ Time Frame: 6 weeks ]
Mean change from baseline to the 6-week study endpoint in CGI-S score.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder With Mixed Features
Intervention  ICMJE
  • Drug: Lurasidone
    20, 40, 60 mg, flexible dose, once daily PM 6 weeks
    Other Name: Latuda
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Lurasidone
    Lurasidone 20, 40 or 60 mg
    Intervention: Drug: Lurasidone
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2015)
211
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2011)
200
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation,   Serbia,   Ukraine,   United Kingdom,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT01421134
Other Study ID Numbers  ICMJE D1050304
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunovion
Study Sponsor  ICMJE Sunovion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director, MD Sunovion
PRS Account Sunovion
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP