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Major Depressive Disorder With Mixed Features (RESOLVE2)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01423240
First received: August 23, 2011
Last updated: December 11, 2012
Last verified: December 2012
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
 Drug: Lurasidone 20 mg
Drug: Lurasidone 60 mg
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, Fixed-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 in MADRS total score after 6 weeks of treatment


Secondary Outcome Measures:
  • CGI-S [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Global severity assessed by the CGI-S score (depression)


Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lurasidone 20 mg Drug: Lurasidone 20 mg
Lurasidone 20 mg once daily orally in the evening
Other Name: Latuda
Experimental: Lurasidone 60 mg Drug: Lurasidone 60 mg
Lurasidone 60 mg once daily orally in the evening
Other Name: Latuda
Placebo Comparator: Placebo Drug: Placebo
Placebo once daily orally in the evening

  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 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423240

  Show 27 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01423240     History of Changes
Other Study ID Numbers: D1050305
Study First Received: August 23, 2011
Last Updated: December 11, 2012
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 19, 2013