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

NCT01421134 | Completed Phase 3 Results DMC

• 1 other identifier: D1050304
• Study Type: interventional
• Target: 211
• Locations: 5 countries
• Sites: 43

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.

Conditions

Major Depressive Disorder With Mixed Features

Keywords

depression; Lurasidone; Latuda

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores

  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.

  Baseline to Week 6

Secondary Outcomes (6)

• 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

• Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score

  Baseline to Week 6

• Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score

  Baseline to Week 6

• Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score

  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

Study Arms (2)

Lurasidone

EXPERIMENTAL

Lurasidone 20, 40 or 60 mg

Drug: Lurasidone

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Lurasidone DRUG

20, 40, 60 mg, flexible dose, once daily PM 6 weeks

Also known as: Latuda

Lurasidone

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (43)

Birmingham Psychiatry Pharmaceutical Studies, Inc.

Birmingham, Alabama, 35226, United States

Location

Synergy Clinical Research Center

Escondido, California, 92025, United States

Location

Collaborative Neuroscience Network Inc.

Garden Grove, California, 92845, United States

Location

Stanford -VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Clinical Innovations Inc.

Riverside, California, 92506, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92123, United States

Location

Florida Clinical Research Center, LLC

Sarasota, Florida, 34201, United States

Location

Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders

Boston, Massachusetts, 02114, United States

Location

St. Charles Psychiatric Associates/Midwest Research Group

Saint Charles, Missouri, 63301, United States

Location

Social Psychiatric Research Inst. (SPRI) Clinical Trials

Brooklyn, New York, 11235, United States

Location

Village Clinical Research Inc.

New York, New York, 10003, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Behavioral Medical Research of Staten Island

Staten Island, New York, 10305, United States

Location

Psychiatry and Behavioral Sciences, Duke

Durham, North Carolina, 27705, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

CRI Worldwide - Kirkbride

Philadelphia, Pennsylvania, 19139, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Dept. of Psychiatry, UT Southwestern Medical Center

Dallas, Texas, 75390-8849, United States

Location

Grayline Clinical Drug Trials

Wichita Falls, Texas, 76309, United States

Location

Saint Nicholas Psychiatric Hospital.

Saint Petersburg, 190121, Russia

Location

City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit)

Saint Petersburg, 191119, Russia

Location

Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva"

Saint Petersburg, 193167, Russia

Location

Municipal Healthcare Institution"City Clinical Hospital #2, n.a. V.I. Razumovsky" of Healthcare Committee of Administration of Municipal Entity "City of Saratov"

Saratov, 410028, Russia

Location

State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia,

Saratov, 410060, Russia

Location

Limited Liability Company "Research-And-Educational Centre of Psychotherapy "Podderzhka"

Stavropol, 355000, Russia

Location

Institute of Mental Health

Belgrade, 11000, Serbia

Location

Psychiatric Clinic, Clinical Hospital Center"Dr. Dragisa Misovic-Dedinje"

Belgrade, 11000, Serbia

Location

Health Centre Cacak Department of Psychiatry

Čačak, 32000, Serbia

Location

Clinical Center Nis, Psychiatric Clinic

Gornja Toponica, 18201, Serbia

Location

Clinical Center Kragujevac, Psychiatric Clinic

Kragujevac, 34000, Serbia

Location

Clinic for Mental Health, Clinical Center Nis

Niš, 18000, Serbia

Location

Special Hospital for Psychiatric Diseases "Sveti Vracevi"

Vojvodina, 23330, Serbia

Location

Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"

Vršac, 26300, Serbia

Location

General Hospital "Djordje Joanovic" Psychiatric Dept.

Zrenjanin, 23000, Serbia

Location

Dnipropetrovsk Regional Clinical Hospital named Mechnikov

Dnipropetrovsk, 49005, Ukraine

Location

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

Kharkiv, 61068, Ukraine

Location

Communal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association "Psychiatric Dept. #10 and Psychiatric Dept. #2

Kyiv, 08631, Ukraine

Location

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

Luhansk, 91045, Ukraine

Location

Municipal Institution "Lviv Regional State Clinical Psychiatric Hospital, Department #20

Lviv, 79021, Ukraine

Location

Odesa Regional Psychoneurological Dispensary, Outpatient Dept.

Odesa, 65014, Ukraine

Location

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

Vinnytsia, 21018, Ukraine

Location

MAC Clinical Research Limited

Cannock, WS11 0BN, United Kingdom

Location

MAC Clinical Research Limited

Manchester, M32 0UT, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 30086213 DERIVED

• 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.

  PMID: 29943445 DERIVED

• 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.

  PMID: 26908089 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: 1-866-503-6351
• Organization: Sunovion

clinicaltrialdisclosure@sunvion.com

1-866-503-6351

Study Officials

• Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: August 22, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 15, 2016
• Results First Posted: October 9, 2015

Record last verified: 2016-07

Locations

RU (6); UA (7); US (19); GB (2); SE (9)