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

This study is currently recruiting participants.
Verified April 2013 by Sunovion
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01421134
First received: August 17, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Depression
Drug Information available for: Lurasidone
U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:
  • MADRS [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Mean change from baseline to the 6-week study endpoint in MADRS score


Secondary Outcome Measures:
  • CGI-S [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Mean change from baseline to the 6-week study endpoint in CGI-S score.


Estimated Enrollment: 200
Study Start Date: September 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421134

Contacts
Contact: Study Manager 1-888-394-7377

  Show 34 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: April 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
depression
Lurasidone
Latuda

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

ClinicalTrials.gov processed this record on May 16, 2013