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

Study Timeline

• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-22
• Study Start: 2011-09
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-09-10
• Results First Submitted QC: 2015-09-10
• Results First Posted: 2015-10-09
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-15

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)

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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.

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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"; 🇷🇸 Vrsac, Serbia

Special Hospital for Psychiatric Diseases "Sveti Vracevi"; 🇷🇸 Vojvodina, Serbia

Clinical Innovations Inc.; 🇺🇸 Riverside, California, United States

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders; 🇺🇸 Boston, Massachusetts, United States

CRI Worldwide - Kirkbride; 🇺🇸 Philadelphia, Pennsylvania, United States

Dept. of Psychiatry, UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Midwest Clinical Research Center; 🇺🇸 Dayton, Ohio, United States

State Institution "Institute of Neurology, Psychiatry and Narcology NAMS of Ukraine", Dep. of Clinical, Social and Child Psychiatry; 🇺🇦 Kharkiv, Ukraine

State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia,; 🇷🇺 Saratov, Russian Federation

Psychiatry and Behavioral Sciences, Duke; 🇺🇸 Durham, North Carolina, United States

Limited Liability Company "Research-And-Educational Centre of Psychotherapy "Podderzhka"; 🇷🇺 Stavropol, Russian Federation

Health Centre Cacak Department of Psychiatry; 🇷🇸 Cacak, Serbia

Clinic for Mental Health, Clinical Center Nis; 🇷🇸 Nis, Serbia

MAC Clinical Research Limited; 🇬🇧 Manchester, United Kingdom

Clinical Center Nis, Psychiatric Clinic; 🇷🇸 Gornja Toponica, Serbia

Dnipropetrovsk Regional Clinical Hospital named Mechnikov; 🇺🇦 Dnipropetrovsk, Ukraine

Psychiatric Clinic, Clinical Hospital Center"Dr. Dragisa Misovic-Dedinje"; 🇷🇸 Belgrade, Serbia

Communal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association "Psychiatric Dept. #10 and Psychiatric Dept. #2; 🇺🇦 Kyiv, Ukraine

Municipal Institution "Lviv Regional State Clinical Psychiatric Hospital, Department #20; 🇺🇦 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; 🇺🇦 Vinnytsya, Ukraine

Village Clinical Research Inc.; 🇺🇸 New York, New York, United States

FutureSearch Trials of Dallas, LP; 🇺🇸 Dallas, Texas, United States

Birmingham Psychiatry Pharmaceutical Studies, Inc.; 🇺🇸 Birmingham, Alabama, United States

Clinical Center Kragujevac, Psychiatric Clinic; 🇷🇸 Kragujevac, Serbia

Saint Nicholas Psychiatric Hospital.; 🇷🇺 St. Petersburg, Russian Federation

City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit); 🇷🇺 St. Petersburg, Russian Federation

Institute of Mental Health; 🇷🇸 Belgrade, Serbia

General Hospital "Djordje Joanovic" Psychiatric Dept.; 🇷🇸 Zrenjanin, Serbia

Behavioral Medical Research of Staten Island; 🇺🇸 Staten Island, New York, United States

St. Charles Psychiatric Associates/Midwest Research Group; 🇺🇸 St. Charles, Missouri, United States

Finger Lakes Clinical Research; 🇺🇸 Rochester, New York, United States

Florida Clinical Research Center, LLC; 🇺🇸 Sarasota, Florida, United States

Synergy Clinical Research Center; 🇺🇸 Escondido, California, United States

Stanford -VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States

Social Psychiatric Research Inst. (SPRI) Clinical Trials; 🇺🇸 Brooklyn, New York, United States

Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva"; 🇷🇺 St. Petersburg, Russian Federation

Grayline Clinical Drug Trials; 🇺🇸 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"; 🇷🇺 Saratov, Russian Federation

"Lugansk State Medical University"Chair of Psychiatry, Narcology and Medical Psychology; Lugansk Regional Clinical Psychoneurological Hospital, Dispensary Dept. for adults; 🇺🇦 Lugansk, Ukraine

Odesa Regional Psychoneurological Dispensary, Outpatient Dept.; 🇺🇦 Odesa, Ukraine

Collaborative Neuroscience Network Inc.; 🇺🇸 Garden Grove, California, United States