Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia

PHASE3CompletedINTERVENTIONAL
Enrollment

515

Participants

Timeline

Start Date

December 15, 2017

Primary Completion Date

May 26, 2020

Study Completion Date

February 15, 2021

Conditions
Negative Symptoms of Schizophrenia
Interventions
DRUG

Placebo Oral Tablet

Placebo administered as a single dose once daily

DRUG

Roluperidone 32 mg

Roluperidone administered as a single dose once daily

DRUG

Roluperidone 64 mg

Roluperidone administered as a single dose once daily

Trial Locations (39)

10962

The Nathan Kline Institute for Psychiatric Research, Orangeburg

30331

Atlanta Center for Medical Research, Atlanta

33161

Behavioral Clinical Research, Inc, North Miami

33334

Research Centers of America, LLC, Oakland Park

60640

Uptown Research Institute LLC, Chicago

72758

Woodland Research Northwest, Rogers

75080

Pillar Clinical Research LLC, Richardson

75115

InSite Clinical Research LLC, DeSoto

90230

ProScience Research Group, Culver City

90502

Collaborative Neuroscience Network, LLC., Torrance

91950

Synergy Clinical Center, National City

92845

Collaborative Neuroscience Network, LLC., Garden Grove

08009

Hassman Research Institute, LLC., Berlin

Unknown

"State Psychiatric Hospital - Tserova Koria; Department for Active Treatment of Severe Psychosis - male; Department for Active Treatment of Severe Psychosis - male", Tserova Koria

"Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD Department For Treatment of Emergency Psychiatry Conditions", Burgas

State Psychiatry Hospital - Lovech, Lovech

"State Psychiatry Hospital Sveti Ivan Rilski Department of General Psychiatry for adults closed type - males; Department of General Psychiatry for adults closed type - females", Novi Iskar

"'Mental Health Center Plovdiv-EOOD Department for treatment of acute female/male psychoses with endogenous, exogenous, organic psychotic disturbances of the personality", Plovdiv

"Multiprofile Hospital for Active Treatment - Targovishte AD Department of Psychiatry", Targovishte

"Mental Health Center - Vratsa General Psychiatric Department", Vratsa

Samodzielny Publiczny Psychiatryczny zakład opieki zdrowotnej im Dr. Stanisława Deresza w Choroszczy, Choroszcz

Medical University of Gdańsk, Department of Psychiatry UCK, Gdansk

Klinika Psychiatryczna Inventiva, Tuszyn

"Communal Institution Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov, Regional Centre for Psychosomatic Disorders based on Psychoneurological Department", Dnipro

Ivano-Frankivsk National Medical University (IFNMU) - Regional Psycho-Neurological Hospital #3, Ivano-Frankivsk

"Kharkiv Railway Clinical Hospital N°1 of Branche Health Center of the Public joint stock company Ukrainian Railway, Psychiatry Department", Kharkiv

"State Institution Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Science of Ukraine, Department of Emergency Psychiatry and Narcology", Kharkiv

"State Institution Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Science of Ukraine, Department of Neuroses and Borderline Conditions", Kharkiv

"State Institution Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Sciences of Ukraine, Department of Clinical, Social and Child Psychiatry", Kharkiv

"Kyiv Regional Medical Incorporation Psychiatry, Centre of Novel Treatment and Rehabilitation of Psychotic Disorders based on Department #29 and Department #30", Kyiv

"Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #20", Lviv

"Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatry Hospital, General Psychiatric Mixed Department #25", Lviv

Odessa Regional Medical Centre of Mental Health, Dept. #6 (male), Dept. #12 (female), Odesa

"Kyiv Regional Medical Incorporation Psychiatry, Centre of Novel Treatment and Rehabilitation of Psychotic Disorders based on Department #29 and Department #30", Oleksandrivka

"Ukrainian medical stomatological academy, Chair of psychiatry, narcology and medical psychology based on Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev, female acute general psych. dept. 5-b, male acute general psych. dept 2-a", Poltava

"Communal Institution Cherkasy Regional Psychiatric Hospital", Smila

Municipal Institution Kherson Regional Psychiatric Hospital of Regional Council, Stepanovka

Ternopil Regional Municipal Clinical Psychoneurological Hospital, Ternopil

"Municipal Institution Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko, Male Department No 14, Female Department No 15", Vinnytsia

Sponsors
All Listed Sponsors
lead

Minerva Neurosciences

INDUSTRY

NCT03397134 - Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia | Biotech Hunter | Biotech Hunter