A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression

PHASE2CompletedINTERVENTIONAL
Enrollment

344

Participants

Timeline

Start Date

June 26, 2018

Primary Completion Date

April 23, 2020

Study Completion Date

April 23, 2020

Conditions
Depressive EpisodeBipolar 1 Depression
Interventions
DRUG

SEP-4199 200 mg

SEP-4199 200 mg/day (supplied in two 100mg tablets)

DRUG

SEP-4199 400 mg

SEP-4199 400 mg/day (supplied in two 200mg tablets

DRUG

Placebo

Placebo (supplied in two tablets/day)

Trial Locations (87)

1202

Mental Health Center - Sofia EOOD, Sofia

6100

MHAT-Dr. Hristo Stambolski EOOD, Department of Psychiatry, Kazanlak

6600

State Psychiatric Hospital-Kardzhali, Kardzhali

7003

Mental Health Center - Ruse EOOD, Rousse

8000

Mental Health Centre -Prof. Dr. Ivan Temkov - Burgas EOOD, Burgas

9747

Neli Nikolova Todorova, MD ,State Psychatric Hospital - s. Tsarev brod, Shumen

11000

Bel Medic General Hospital, Belgrade

"Clinical Center Dr. Dragisa Misovic-Dedinje", Belgrade

Clinical Center of Serbia, Belgrade

General Hospital Euromedik, Belgrade

Institute of Mental Health, Belgrade

20708

Communal Institution Cherkasy regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12, Smila

21005

communal Institution Acad. O.I. Yushchenko Vinnytsia Regional Psychoneurological hosital, Male Deparmtent #14, Female Department #15, Vinnytsia M.I. Pyrogov National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with the Course of P, Vinnytsia

26220

"Special Hospital for Psychiatric Diseases Kovin", Kovin

30331

Atlanta Center for Medical Research, Atlanta

32256

Clinical Neuroscience Solutions, Inc., Jacksonville

32801

Clinical Neuroscience Solutions, Inc., Orlando

34000

Clinical Center Kragujevac, Kragujevac

61068

State Institution Institue of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Emergency sychiatry and Narcology, Kharkiv

State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Borderline Psychiatry, Kharkiv

65006

Communal Institution Odesa regional Medical Center of Mental Health, Dep #6 (Male), Dep #12 (Female), Odesa

67513

Communal Institution Odesa Regional Psychiatric Hospital #2, Department #14 (female), Department #16 (male), Odesa

73488

CI Kherson Regional Psychiatric Hospital of Kherson Regional Council, Male Dep of Psychiatry #3, Female Dep of Psychiatry #10, Kherson

76011

Regional Psychoneurological Hospital #3, Department of Neurosis and Borderline States # 8, Ivano-Frankivsk

85101

Vavrusova Consulting s.r.o. Psychiatricka ambulancia, Bratislava

88000

Transcarpathian Regional Narcological Dispensary, Department of Psychiatry, Uzhhorod

90703

CNS Research Science, Inc., Cerritos

92103

Artemis Insitute for Clinical Research, San Diego

92845

Collaborative Neuroscience Network, LLC, Garden Grove

97901

Psycholine s.r.0. Psychiatricka ambulancia, Rimavská Sobota

98201

Eastside Therapeutic Resource dba Core Clinical Research, Everett

107076

"State Budgetary Institution of Healthare of the City of Moscow Psychiatric clinical Hospital #4 n.a. P.B. Gannushkin of the Department of Healthcare of the City o Moscow Branch Psychiatric hospital n.a. V.A. Gilyarovsky", Moscow

190121

"Saint Petersburg State Institution of Healthcare Psychiatric Hospital of Sain Nikolai hudotvorets ", Saint Petersburg

192019

"Federal State Budgetary Institution National Medical Research Centre of psychiatry and nuerology named after V.M. Bekhterev of the Ministry of Healthcare of the Russian Federation, department #12", Saint Petersburg

199106

"Stain Petersburg State Budgetary Institution of Healthcare Psychoneurological Dispensary #1", Saint Petersburg

344000

"Limited Liability Company Treatment and Rehabilitational Scientific Center Phoenix", Rostov-on-Don

398007

Lipetsk regional psychoneurological hospital, Lipetsk

410060

"State Institution of Healtcare Regional Clinical Psychiatric Hospital of Saint Sofia", Saratov

603155

"State Budgetary Institution of Healthcare of Nizhniy Novgorod region Clinical Psychiatric Hospital #1 of Nizhniy Novgorod", Nizhny Novgorod

634009

"Limited Liability Company Clinic StoLet", Tomsk

644070

"Budgetary Institution of Healthcare of Omsk region Clinical Psychiatric Hospital named after N.N. Solodnikov", Omsk

Unknown

Fukuoka University Hospital, Fukuoka

Hatakeyama Clinic, Department of Psychiatry, Fukuoka

Hiro Mental Clinic, Department of Psychiatry, Fukuoka

Kokura Mental Clinic, Fukuoka

Kuramitsu Hospital, Department of Psychiatry, Fukuoka

Shinseikai Kaku Mental Clinic, Department of Psychiatry, Fukuoka

Someikai Kanagami Clinic, Department of Psychiatry, Fukuoka

Jisenkai Nanko Psychiatric Institute, Department of Psychiatry, Fukushima

Takahashi Psychiatric Clinic, Hyōgo

Azamino Mental clinic, Department of Psychiatry, Kanagawa

Medical Corporation Seishinkai Kishiro Mental Clinic, Department of Psychiatry, Kanagawa

Musashikosugi J. Kokorono Clinic, Kanagawa

Yokohama Onoecho Clinic, Department of Psychiatry, Kanagawa

Yutaka Clinic, Kanagawa

SagaArashiyama / Tanaka Clinic, Department of Psychiatry, Kyoto

Minami-aoyama Anique Street Clinic, Department of Psychiatry, Minato-Ku, Tokyo

Clinic Sophia, Okayama

Asakayama Hospital, Osaka

Koshokai Ainhanazono Hospital, Osaka

Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital, Osaka

Etoh Mental Clinic Meguro, Department of Psychiatry, Tokyo

Himorogi Psychiatric Institute, Department of Psychiatry, Tokyo

JCHO Yokyo Shinjuku Medical Center, Tokyo

Jisenkai Hozumi Himorogi Clinic, Department of Psychiatry, Tokyo

Maynds Tower Mental Clinic, Department of Psychiatry, Tokyo

Nishi-shinjuku Concieria Clnic, Tokyo

Ohwa Mental clinic, Department of Psychiatry, Tokyo

Sangenjaya Nakamura Mental Clinic, Department of Psychiatry, Tokyo

Sangenjaya Neurology-Psychosomatic Clinic, Department of Psychiatry, Tokyo

Senzoku Psychosomatic Clinic, Department of Psychiatry, Tokyo

Shinjuku Research Park Clinic, Tokyo

Tamaki Clinic, Department of Psychiatry, Tokyo

Uguisudani Mental Clinic, Department of Psychiatry, Tokyo

Yoyogi Mental Clinic, Tokyo

Specjalistyczna Praktyka Lekarska Marek Domanski, Lublin

572-0854

Nagaokai Neyagawa Sanitorium, Osaka

85-080

Przychodnia Srodmiescie Sp. z.o.o., Bydgoszcz

64-100

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS, Leszno

60-744

Filip Rybakowski Specjalistyczna Praktka Lekarska, Poznan

83-000

"Poradnia Zdrowia Psychicznego Syntonia", Pruszcz Gdański

87-100

Gabinet Lekarski Torunskie Centrum PsychiatriI NEUROMED, Torun

Osrodek Badan Klinicznych Clinsante Spolka Cywilna, Torun

04001

Investa spol. s.r.o., Kosice Psychiatricka ambulancia, Košice

08901

Centrum zdravia R.B.K. Psychiatricka ambulancia, Svidník

09301

Crystal Comfort s.r.o. Psychiatricka ambulancia, Vranov nad Topľou

08631

Communal Institution (CI) of Kyiv Regional Council regional Psychiatric and Narcological Medical Assocation, Dep #10 (male), Dep #2 (female), Kyiv

All Listed Sponsors
lead

Sumitomo Pharma America, Inc.

INDUSTRY

NCT03543410 - A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression | Biotech Hunter | Biotech Hunter