Major Depressive Disorder With Mixed Features

Major Depressive Disorder Clinical Trial

— RESOLVE2  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01423240
• Other study ID #: D1050305
• Status: Withdrawn
• Phase: Phase 3
• First received: August 23, 2011
• Last updated: December 11, 2012
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Lurasidone 20 mg
Lurasidone 20 mg once daily orally in the evening
• Lurasidone 60 mg
Lurasidone 60 mg once daily orally in the evening
• Placebo
Placebo once daily orally in the evening

Locations

Country	Name	City	State
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Comprehensive NeuroScience Inc.	Atlanta	Georgia
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Birmingham Research Group	Birmingham	Alabama
United States	Montefiore Medical Center; Anxiety & Depression Clinic; Dept. of Psychiatry	Bronx	New York
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	New Hope Clinical Research	Hickory	North Carolina
United States	Hawaii Clinical Research Center	Honolulu	Hawaii
United States	Sun Valley Behavioral Medical	Imperial	California
United States	Goldpoint Clinical Research	Indianapolis	Indiana
United States	Florida Research Center	Maitland	Florida
United States	Suburban Research Associates	Media	Pennsylvania
United States	Miami Research	Miami	Florida
United States	University of Miami, Miller School	Miami	Florida
United States	Synergy Clinical Research Center	National City	California
United States	Medical & Behavioral Health Research	New York	New York
United States	Excell Research	Oceanside	California
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	Pacific Clinical Research Medical Group	Orange	California
United States	Department of Psychiatry, University of Utah Health Sciences Center	Salt Lake City	Utah
United States	Harry Croft and Associates	San Antonio	Texas
United States	University of Texas Health Science Center	San Antonio	Texas
United States	SMRI	Sherman Oaks	California
United States	Psychiatric Medicine Associates	Skokie	Illinois
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas
United States	CRI Worldwide	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MADRS	Mean change from baseline in MADRS total score after 6 weeks of treatment	6 weeks	No
Secondary	CGI-S	Global severity assessed by the CGI-S score (depression)	6 weeks	No