Major Depressive Disorder With Mixed Features (RESOLVE2)

December 11, 2012 updated by: Sunovion

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Birmingham Research Group
    • California
      • Imperial, California, United States, 92251
        • Sun Valley Behavioral Medical
      • National City, California, United States, 91950
        • Synergy Clinical Research Center
      • Oceanside, California, United States, 92056
        • Excell Research
      • Orange, California, United States, 92868
        • Pacific Clinical Research Medical Group
      • Sherman Oaks, California, United States, 91403
        • SMRI
    • Florida
      • Gainesville, Florida, United States, 32607
        • Sarkis Clinical Trials
      • Maitland, Florida, United States, 32751
        • Florida Research Center
      • Miami, Florida, United States, 33136
        • University of Miami, Miller School
      • Miami, Florida, United States, 33143
        • Miami Research
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30328
        • Comprehensive NeuroScience Inc.
    • Hawaii
      • Honolulu, Hawaii, United States, 86813
        • Hawaii Clinical Research Center
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Psychiatric Medicine Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Goldpoint Clinical Research
    • New Jersey
      • Willingboro, New Jersey, United States, 08054
        • CRI Worldwide
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center; Anxiety & Depression Clinic; Dept. of Psychiatry
      • New York, New York, United States, 10023
        • Medical & Behavioral Health Research
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • New Hope Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Sooner Clinical Research
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Center for Clinical Research
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center
      • San Antonio, Texas, United States, 78229
        • Harry Croft and Associates
      • Wichita Falls, Texas, United States, 76309
        • Grayline Clinical Drug Trials
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Department of Psychiatry, University of Utah Health Sciences Center
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo once daily orally in the evening
Experimental: Lurasidone 20 mg
Drug: Lurasidone 20 mg
Lurasidone 20 mg once daily orally in the evening
Other Names:
  • Latuda
Experimental: Lurasidone 60 mg
Drug: Lurasidone 60 mg
Lurasidone 60 mg once daily orally in the evening
Other Names:
  • Latuda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MADRS
Time Frame: 6 weeks
Mean change from baseline in MADRS total score after 6 weeks of treatment
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGI-S
Time Frame: 6 weeks
Global severity assessed by the CGI-S score (depression)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 24, 2011

First Posted (Estimate)

August 25, 2011

Study Record Updates

Last Update Posted (Estimate)

December 13, 2012

Last Update Submitted That Met QC Criteria

December 11, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1050305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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