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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01421134
First received: August 17, 2011
Last updated: October 1, 2014
Last verified: October 2014
  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.


Condition Intervention Phase
Major Depressive Disorder With Mixed Features
Drug: Lurasidone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Mean Change from baseline to the 6-week study endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) total scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline to the 6-week study endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to endpoint in the Young Mania Rating Scale (YMRS) score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to endpoint in the Sheehan Disability Scale (SDS) total score the SDS subscale scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Mean change in baseline to endpoint in the Hamilton Rating Scale for Anxiety(HAM-A) total score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve a response, defined as ≥ 50% reduction from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at endpoint [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve a remission, defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≤ 12 at endpoint [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with treatment-emergent mania, assessed by a Young Mania Rating Scale (YMRS) total score of ≥ 16 on any two consecutive visits or at the final assessment, or an AE of mania or hypomania [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • • Proportion of subjects with AEs and SAEs, and discontinuations due to AEs and SAEs [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Vital signs and ECG measurements [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Movement disorders assessed by the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson-Angus Rating Scale (SARS) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Weight and laboratory measures [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Mean change from baseline to endpoint in sexual functioning based on Changes in Sexual Functioning Questionnaire (CSFQ) total score and CSFQ subscale scores [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Frequency and severity of suicidality using Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 187
Study Start Date: September 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lurasidone
Lurasidone 20, 40 or 60 mg
Drug: Lurasidone
20, 40, 60 mg, flexible dose, once daily PM 6 weeks
Other Name: Latuda
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
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 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.
  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: NCT01421134

  Show 43 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01421134     History of Changes
Other Study ID Numbers: D1050304
Study First Received: August 17, 2011
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Ukraine: Ministry of Health
Russia: Ministry of Health of the Russian Federation
UK: Ministry of Health

Keywords provided by Sunovion:
depression
Lurasidone
Latuda

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014