Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose

Phase 3

Completed

Conditions: Major Depressive Disorder With Mixed Features

Interventions: Drug: Lurasidone
Drug: Placebo

Registration Number: NCT01421134

Lead Sponsor: Sumitomo Pharma America, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 211

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lurasidone	Lurasidone	Lurasidone 20, 40 or 60 mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores	Baseline to Week 6	The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score	Baseline to Week 6	The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score	Baseline to Week 6	The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score	Baseline to Week 6	The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.
Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)	Baseline to Week 6
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).	Baseline to Week 6
Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score	Baseline to Week 6	The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).

Trial Locations

Locations (42): Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"
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Vrsac, Serbia
Special Hospital for Psychiatric Diseases "Sveti Vracevi"
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Vojvodina, Serbia
Clinical Innovations Inc.
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Riverside, California, United States
Artemis Institute for Clinical Research
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San Diego, California, United States
Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders
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Boston, Massachusetts, United States
CRI Worldwide - Kirkbride
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Philadelphia, Pennsylvania, United States
Dept. of Psychiatry, UT Southwestern Medical Center
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Dallas, Texas, United States
Midwest Clinical Research Center
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Dayton, Ohio, United States
State Institution "Institute of Neurology, Psychiatry and Narcology NAMS of Ukraine", Dep. of Clinical, Social and Child Psychiatry
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Kharkiv, Ukraine
State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia,
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Saratov, Russian Federation
Psychiatry and Behavioral Sciences, Duke
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Durham, North Carolina, United States
Limited Liability Company "Research-And-Educational Centre of Psychotherapy "Podderzhka"
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Stavropol, Russian Federation
Health Centre Cacak Department of Psychiatry
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Cacak, Serbia
Clinic for Mental Health, Clinical Center Nis
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Nis, Serbia
MAC Clinical Research Limited
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Manchester, United Kingdom
Clinical Center Nis, Psychiatric Clinic
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Gornja Toponica, Serbia
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
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Dnipropetrovsk, Ukraine
Psychiatric Clinic, Clinical Hospital Center"Dr. Dragisa Misovic-Dedinje"
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Belgrade, Serbia
Communal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association "Psychiatric Dept. #10 and Psychiatric Dept. #2
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Kyiv, Ukraine
Municipal Institution "Lviv Regional State Clinical Psychiatric Hospital, Department #20
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Lviv, Ukraine
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
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Vinnytsya, Ukraine
Village Clinical Research Inc.
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New York, New York, United States
FutureSearch Trials of Dallas, LP
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Dallas, Texas, United States
Birmingham Psychiatry Pharmaceutical Studies, Inc.
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Birmingham, Alabama, United States
Clinical Center Kragujevac, Psychiatric Clinic
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Kragujevac, Serbia
Saint Nicholas Psychiatric Hospital.
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St. Petersburg, Russian Federation
City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit)
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St. Petersburg, Russian Federation
Institute of Mental Health
🇷🇸
Belgrade, Serbia
General Hospital "Djordje Joanovic" Psychiatric Dept.
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Zrenjanin, Serbia
Behavioral Medical Research of Staten Island
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Staten Island, New York, United States
St. Charles Psychiatric Associates/Midwest Research Group
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St. Charles, Missouri, United States
Finger Lakes Clinical Research
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Rochester, New York, United States
Florida Clinical Research Center, LLC
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Sarasota, Florida, United States
Synergy Clinical Research Center
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Escondido, California, United States
Stanford -VA Palo Alto Health Care System
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Palo Alto, California, United States
Social Psychiatric Research Inst. (SPRI) Clinical Trials
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Brooklyn, New York, United States
Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva"
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St. Petersburg, Russian Federation
Grayline Clinical Drug Trials
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Wichita Falls, Texas, United States
Municipal Healthcare Institution"City Clinical Hospital #2, n.a. V.I. Razumovsky" of Healthcare Committee of Administration of Municipal Entity "City of Saratov"
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Saratov, Russian Federation
"Lugansk State Medical University"Chair of Psychiatry, Narcology and Medical Psychology; Lugansk Regional Clinical Psychoneurological Hospital, Dispensary Dept. for adults
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Lugansk, Ukraine
Odesa Regional Psychoneurological Dispensary, Outpatient Dept.
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Odesa, Ukraine
Collaborative Neuroscience Network Inc.
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Garden Grove, California, United States