Clinical trial NCT01423240: Major Depressive Disorder With Mixed Features
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depression
Lurasidone
Latuda
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: MADRS
timeFrame: 6 weeks
Secondary outcomes:
measure: CGI-S
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Research Group
state: Alabama
city: Imperial
country: United States
facility: Sun Valley Behavioral Medical
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Orange
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Sherman Oaks
country: United States
facility: SMRI
state: California
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Maitland
country: United States
facility: Florida Research Center
state: Florida
city: Miami
country: United States
facility: University of Miami, Miller School
state: Florida
city: Miami
country: United States
facility: Miami Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Comprehensive NeuroScience Inc.
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Clinical Research Center
state: Hawaii
city: Skokie
country: United States
facility: Psychiatric Medicine Associates
state: Illinois
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research
state: Indiana
city: Willingboro
country: United States
facility: CRI Worldwide
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center; Anxiety & Depression Clinic; Dept. of Psychiatry
state: New York
city: New York
country: United States
facility: Medical & Behavioral Health Research
state: New York
city: Hickory
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: San Antonio
country: United States
facility: Harry Croft and Associates
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Salt Lake City
country: United States
facility: Department of Psychiatry, University of Utah Health Sciences Center
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Goldberg JF, Siu C, Mao Y, Tsai J, Pikalov A, Calabrese JR, Loebel A. Major depressive disorder with mixed features and treatment response to lurasidone: A symptom network model. J Affect Disord. 2020 Dec 1;277:1045-1054. doi: 10.1016/j.jad.2020.08.048. Epub 2020 Aug 26.
citation: Suppes T, Silva R, Cucchiaro J, Mao Y, Targum S, Streicher C, Pikalov A, Loebel A. Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features: A Randomized, Double-Blind, Placebo-Controlled Study. Am J Psychiatry. 2016 Apr 1;173(4):400-7. doi: 10.1176/appi.ajp.2015.15060770. Epub 2015 Nov 10.