Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Major Depressive Disorder With Mixed Features |
| Intervention | Drug: Lurasidone Drug: Placebo |
| Phase | Phase 3 |
| Sponsor | Sunovion |
| Responsible Party | Sunovion |
| ClinicalTrials.gov Identifier | NCT01421134 |
| First Received | August 17, 2011 |
| Last Updated | April 4, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 17, 2011 |
|---|---|
| Last Updated Date | April 4, 2014 |
| Start Date | September 2011 |
| Estimated Primary Completion Date | October 2014 |
| Current Primary Outcome Measures | Mean Change from baseline to the 6-week study endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) total scores [Time Frame: 6 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
| 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 Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Major Depressive Disorder With Mixed Features |
| Intervention | Drug: Lurasidone 20, 40, 60 mg, flexible dose, once daily PM 6 weeks Other Names: LatudaDrug: Placebo Placebo |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 200 |
| Estimated Completion Date | October 2014 |
| Estimated Primary Completion Date | October 2014 |
| 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Study Manager 1-888-394-7377 |
| Location Countries | United States, Russian Federation, Serbia, Ukraine, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01421134 |
|---|---|
| Other Study ID Numbers | D1050304 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Sunovion |
| Study Sponsor | Sunovion |
| Collaborators | Not Provided |
| Investigators | Study Director: Medical Director, MD Sunovion |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| Birmingham Psychiatry Pharmaceutical Studies, Inc. | Birmingham, Alabama, United States, 35226 Completed |
|---|---|
| K&S Professional Research Services | Little Rock, Arkansas, United States, 72201 Withdrawn |
| Synergy Clinical Research Center | Escondido, California, United States, 92025 Completed |
| Collaborative Neuroscience Network Inc. | Garden Grove, California, United States, 92845 Completed |
| Stanford -VA Palo Alto Health Care System | Palo Alto, California, United States, 94304 Completed |
| Clinical Innovations Inc. | Paramount, California, United States, 90723 Withdrawn |
| Clinical Innovations Inc. | Riverside, California, United States, 92506 Completed |
| Artemis Institute for Clinical Research | San Diego, California, United States, 92123 Completed |
| Florida Clinical Research Center, LLC | Sarasota, Florida, United States, 34201 Completed |
| USF-Psychiatry | Tampa, Florida, United States, 33613 Withdrawn |
| Comprehensive NeuroScience, Inc | Atlanta, Georgia, United States, 30328 Withdrawn |
| Atlanta Institute of Medicine & Research | Atlanta, Georgia, United States, 30328 Withdrawn |
| Atlanta Center for Medical Research | Atlanta, Georgia, United States, 30308 Withdrawn |
| Carman Research | Smyrna, Georgia, United States, 30080 Withdrawn |
| Tufts Medical Center | Boston, Massachusetts, United States, 02111 Withdrawn |
| Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders | Boston, Massachusetts, United States, 02114 Completed |
| St. Charles Psychiatric Associates/Midwest Research Group | St. Charles, Missouri, United States, 63301 Completed |
| Social Psychiatric Research Inst. (SPRI) Clinical Trials | Brooklyn, New York, United States, 11235 Completed |
| Village Clinical Research Inc. | New York, New York, United States, 10003 Completed |
| Medical & Behavioral Health Research | New York, New York, United States, 10023 Withdrawn |
| Finger Lakes Clinical Research | Rochester, New York, United States, 14618 Completed |
| Behavioral Medical Research of Staten Island | Staten Island, New York, United States, 10305 Completed |
| Psychiatry and Behavioral Sciences, Duke | Durham, North Carolina, United States, 27705 Completed |
| New Hope Clinical Research | Hickory, North Carolina, United States, 28601 Withdrawn |
| Midwest Clinical Research Center | Dayton, Ohio, United States, 45417 Completed |
| IPS Research | Oklahoma City, Oklahoma, United States, 73103 Withdrawn |
| Lehigh Center for Clinical Research | Allentown, Pennsylvania, United States, 18104 Withdrawn |
| Lehigh Valley Hospital Psychiatry Department | Allentown, Pennsylvania, United States, 18103 Withdrawn |
| CRI Worldwide - Kirkbride | Philadelphia, Pennsylvania, United States, 19139 Completed |
| Lincoln Research | Lincoln, Rhode Island, United States, 02865 Withdrawn |
| FutureSearch Trials | Austin, Texas, United States, 78731 Withdrawn |
| FutureSearch Trials of Dallas, LP | Dallas, Texas, United States, 75231 Completed |
| Dept. of Psychiatry, UT Southwestern Medical Center | Dallas, Texas, United States, 75390-8849 Completed |
| Grayline Clinical Drug Trials | Wichita Falls, Texas, United States, 76309 Completed |
| State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia, | Saratov, Russian Federation, 410060 Contact: Alexander Parashchenko, MD | 78452955048 | iw-irina@yandex.ruPrincipal Investigator: Alexander Parashchenko, MD Recruiting |
| 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, 410028 Contact: Yulia Barylnik, MD | 79272266850 | juljab@yandex.ruPrincipal Investigator: Yulia Barylnik, MD Not yet recruiting |
| City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit) | St. Petersburg, Russian Federation, 191119 Contact: Mikhail Burdukovsky | 7964362 93 53 | pb4@mail.ruPrincipal Investigator: Mikhail Burdukovsky, MD Recruiting |
| Saint Nicholas Psychiatric Hospital. | St. Petersburg, Russian Federation, 190121 Contact: Petr Muchnik, MD | 7 905 2040310 | petr-ne@yandex.ruPrincipal Investigator: Petr Muchnik, MD Recruiting |
| Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva" | St. Petersburg, Russian Federation, 193167 Contact: Nikolay Neznanov, MD | +7 (812) 274 15 84 | neznanov.spbgmu@gmail.comPrincipal Investigator: Nikolay Neznanov, MD Recruiting |
| Institute of Mental Health | Belgrade, Serbia, 11000 Contact: Dusica Lecic Tosevski, MD | +381113307510 | dusica.lecictosevski@gmail.comPrincipal Investigator: Dusica Lecic Tosevski, MD Recruiting |
| Psychiatric Clinic, Clinical Hospital Center"Dr. Dragisa Misovic-Dedinje" | Belgrade, Serbia, 11000 Contact: Vladimir Diligenski, MD | +381113679200 | dilig@eunet.rsPrincipal Investigator: Vladimir Diligenski, MD Recruiting |
| Health Centre Cacak Department of Psychiatry | Cacak, Serbia, 32000 Contact: Slavica Jekic Tanovic, MD | 0038164 2059441 | dsii@open.telekom.rsPrincipal Investigator: Slavica Jekic Tanovic, MD Recruiting |
| Clinical Center Nis, Psychiatric Clinic | Gornja Toponica, Serbia, 18201 Contact: Julijana Nikolic Popovic, MD | +381184601058 | julijana09@gmail.comPrincipal Investigator: Julijana Nikolic Popovic, MD Recruiting |
| Clinical Center Kragujevac, Psychiatric Clinic | Kragujevac, Serbia, 34000 Contact: Slavica Djukic Dejanovic, MD | 38134300320 | slavicadd@gmail.comPrincipal Investigator: Slavica Djukic Dejanovic, MD Recruiting |
| Clinic for Mental Health, Clinical Center Nis | Nis, Serbia, 18000 Contact: Grozdanko Grbesa, MD | +381184232421 | gaga.grbesa@gmail.comPrincipal Investigator: Grozdanko Grbesa, MD Recruiting |
| Special Hospital for Psychiatric Diseases "Sveti Vracevi" | Vojvodina, Serbia, 23330 Contact: Jovanka Petrovic, MD | +381230810054 | petrovicjoka@yahoo.cojmPrincipal Investigator: Jovanka Petrovic, MD Recruiting |
| Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic" | Vrsac, Serbia, 26300 Contact: Veselin Savic, MD | 38163644404 | saradoraves@open.telekom.rsPrincipal Investigator: Veselin Savic, MD Recruiting |
| General Hospital "Djordje Joanovic" Psychiatric Dept. | Zrenjanin, Serbia, 23000 Contact: Tihomir Papic, MD | 38123513556 | papict@yahoo.comPrincipal Investigator: Tihomir Papic, MD Recruiting |
| General Hospital Djordje Joanovic Zrenjanin | Zrenjanin, Serbia, 23000 Contact: Tihomir Papic, MD | 381648291483 | papict@yahoo.comPrincipal Investigator: Tihomor Papic, MD Recruiting |
| Dnipropetrovsk Regional Clinical Hospital named Mechnikov | Dnipropetrovsk, Ukraine, 49005 Contact: Svitlana Moroz, MD | 380 562 473663 | pso@a-teleport.comPrincipal Investigator: Svitlana Moroz, MD Recruiting |
| State Institution "Institute of Neurology, Psychiatry and Narcology NAMS of Ukraine", Dep. of Clinical, Social and Child Psychiatry | Kharkiv, Ukraine, 61068 Contact: Valerii Pidkorytov, MD | 38 050 683 41 33 | pid-vs@ukr.netPrincipal Investigator: Valerii Pidkorytov, MD Recruiting |
| Communal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association "Psychiatric Dept. #10 and Psychiatric Dept. #2 | Kyiv, Ukraine, 08631 Contact: Gennadiy Zilberblat, MD | 0038 066 767 95 51 | g.zilberblatt@rambler.ruPrincipal Investigator: Gennadiy Zilberblatt, MD Recruiting |
| "Lugansk State Medical University"Chair of Psychiatry, Narcology and Medical Psychology; Lugansk Regional Clinical Psychoneurological Hospital, Dispensary Dept. for adults | Lugansk, Ukraine, 91045 Contact: Svitlana Kazakova, MD | 0038 050 598 50 87 | svitlanakazakova@ukr.netPrincipal Investigator: Svitlana Kazakova, md Recruiting |
| Municipal Institution "Lviv Regional State Clinical Psychiatric Hospital, Department #20 | Lviv, Ukraine, 79021 Contact: Kateryna Zakal, MD | 38 067 767 29 19 | kyz971981@rambler.ruPrincipal Investigator: Kateryna Zakal, MD Recruiting |
| Odesa Regional Psychoneurological Dispensary, Outpatient Dept. | Odesa, Ukraine, 65014 Contact: Anatolii Voloshchuk, MD | 38 063 735 65 55 | voloshchuk@smo-ukraine.comPrincipal Investigator: Anatolii Voloshchuk, MD Recruiting |
| 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, 21018 Contact: Oksana Serebrennikova, MD | 0038 093 065 09 05 | oksanaanatolievna@rambler.ruPrincipal Investigator: Oksana Serebrennikova, MD Recruiting |
| MAC Clinical Research Limited | Blackpool, United Kingdom, FY2 0JH Contact: Christopher McWilliam, MD | 441253444451 | chrismcwilliam@macplc.comPrincipal Investigator: Christopher McWilliam, MD Recruiting |
| MAC Clinical Research Limited | Bradford, United Kingdom, BD3 0DQ Contact: Mark Dale, MD | 441274414330 | markdale@macplc.comPrincipal Investigator: Mark Dale, MD Recruiting |
| MAC Clinical Research Limited | Cannock, United Kingdom, WS11 0BN Contact: Balasubramanya Seetharama Rao, MD | 441543501212 | balurao@macplc.comPrincipal Investigator: Balasubramanya Seetharama Rao, MD Recruiting |
| MAC Clinical Research Limited | Manchester, United Kingdom, M32 0UT Contact: Aliya Asher, MD | 441618641670 | aliyaasher@macplc.comPrincipal Investigator: Aliya Asher, MD Recruiting |