Clinical trial NCT01421134: Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder With Mixed Features
Keywords: depression
Lurasidone
Latuda
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-22
Enrollment: 211
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 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.

Primary outcomes:
measure: Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score
timeFrame: Baseline to Week 6
measure: Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score
timeFrame: Baseline to Week 6
measure: Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score
timeFrame: Baseline to Week 6
measure: Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score
timeFrame: Baseline to Week 6
measure: Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).
timeFrame: Baseline to Week 6
measure: Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.
state: Alabama
city: Escondido
country: United States
facility: Synergy Clinical Research Center
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network Inc.
state: California
city: Palo Alto
country: United States
facility: Stanford -VA Palo Alto Health Care System
state: California
city: Riverside
country: United States
facility: Clinical Innovations Inc.
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Sarasota
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders
state: Massachusetts
city: St. Charles
country: United States
facility: St. Charles Psychiatric Associates/Midwest Research Group
state: Missouri
city: Brooklyn
country: United States
facility: Social Psychiatric Research Inst. (SPRI) Clinical Trials
state: New York
city: New York
country: United States
facility: Village Clinical Research Inc.
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research of Staten Island
state: New York
city: Durham
country: United States
facility: Psychiatry and Behavioral Sciences, Duke
state: North Carolina
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Philadelphia
country: United States
facility: CRI Worldwide - Kirkbride
state: Pennsylvania
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Dallas
country: United States
facility: Dept. of Psychiatry, UT Southwestern Medical Center
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Saratov
country: Russian Federation
facility: Municipal Healthcare Institution"City Clinical Hospital #2, n.a. V.I. Razumovsky" of Healthcare Committee of Administration of Municipal Entity "City of Saratov"
city: Saratov
country: Russian Federation
facility: State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia,
city: St. Petersburg
country: Russian Federation
facility: Saint Nicholas Psychiatric Hospital.
city: St. Petersburg
country: Russian Federation
facility: City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit)
city: St. Petersburg
country: Russian Federation
facility: Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva"
city: Stavropol
country: Russian Federation
facility: Limited Liability Company "Research-And-Educational Centre of Psychotherapy "Podderzhka"
city: Belgrade
country: Serbia
facility: Institute of Mental Health
city: Belgrade
country: Serbia
facility: Psychiatric Clinic, Clinical Hospital Center"Dr. Dragisa Misovic-Dedinje"
city: Cacak
country: Serbia
facility: Health Centre Cacak Department of Psychiatry
city: Gornja Toponica
country: Serbia
facility: Clinical Center Nis, Psychiatric Clinic
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac, Psychiatric Clinic
city: Nis
country: Serbia
facility: Clinic for Mental Health, Clinical Center Nis
city: Vojvodina
country: Serbia
facility: Special Hospital for Psychiatric Diseases "Sveti Vracevi"
city: Vrsac
country: Serbia
facility: Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"
city: Zrenjanin
country: Serbia
facility: General Hospital "Djordje Joanovic" Psychiatric Dept.
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk Regional Clinical Hospital named Mechnikov
city: Kharkiv
country: Ukraine
facility: State Institution "Institute of Neurology, Psychiatry and Narcology NAMS of Ukraine", Dep. of Clinical, Social and Child Psychiatry
city: Kyiv
country: Ukraine
facility: Communal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association "Psychiatric Dept. #10 and Psychiatric Dept. #2
city: Lugansk
country: Ukraine
facility: "Lugansk State Medical University"Chair of Psychiatry, Narcology and Medical Psychology; Lugansk Regional Clinical Psychoneurological Hospital, Dispensary Dept. for adults
city: Lviv
country: Ukraine
facility: Municipal Institution "Lviv Regional State Clinical Psychiatric Hospital, Department #20
city: Odesa
country: Ukraine
facility: Odesa Regional Psychoneurological Dispensary, Outpatient Dept.
city: Vinnytsya
country: Ukraine
facility: Vinnytsya National Medical University n.a. M.I. Pyrogov, Dept. of Psychiatry and Narcology, Vinnytsya Regional Psychoneurological Hospital n.a. O.I. Yushchenko, Dept. no. 14, Dept. no 15
city: Cannock
country: United Kingdom
facility: MAC Clinical Research Limited
city: Manchester
country: United Kingdom
facility: MAC Clinical Research Limited
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Clayton AH, Tsai J, Mao Y, Pikalov A, Loebel A. Effect of Lurasidone on Sexual Function in Major Depressive Disorder Patients With Subthreshold Hypomanic Symptoms (Mixed Features): Results From a Placebo-Controlled Trial. J Clin Psychiatry. 2018 Aug 7;79(5):18m12132. doi: 10.4088/JCP.18m12132.
citation: Targum SD, Pendergrass JC, Lee S, Loebel A. Ratings surveillance and reliability in a study of major depressive disorder with subthreshold hypomania (mixed features). Int J Methods Psychiatr Res. 2018 Dec;27(4):e1729. doi: 10.1002/mpr.1729. Epub 2018 Jun 26.
citation: Targum SD, Suppes T, Pendergrass JC, Lee S, Silva R, Cucchiaro J, Loebel A. Major depressive disorder with subthreshold hypomania (mixed features): Clinical characteristics of patients entered in a multiregional, placebo-controlled study. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jul 4;68:9-14. doi: 10.1016/j.pnpbp.2016.02.007. Epub 2016 Feb 22.