Efficacy and Safety of S 47445 Versus Placebo as Adjunctive Treatment in Depressed Patients Not Fully Recovered From Depressive Symptoms With a Current Antidepressant Treatment

PHASE2CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

April 30, 2017

Study Completion Date

April 30, 2017

Conditions
Major Depressive Disorder
Interventions
DRUG

S47445 15mg

One tablet of S47445 15 mg taken orally once a day during breakfast concomitantly to the current selective serotonin reuptake inhibitor treatment, starting the day after inclusion visit and ending the day of the W8 visit.

DRUG

S47445 50mg

One tablet of S47445 50 mg taken orally once a day during breakfast concomitantly to the current selective serotonin reuptake inhibitor treatment, starting the day after inclusion visit and ending the day of the W8 visit.

DRUG

Placebo

One tablet of placebo taken orally once a day during breakfast concomitantly to the current selective serotonin reuptake inhibitor treatment, starting the day after inclusion visit and ending the day of the W8 visit.

Trial Locations (53)

1032

Forras Outpatient Clinic, Budapest

1083

Semmelweis Orvostudomanyi Egyetem, Pszichiatriai es Pszichoterapias Klinika, Budapest

1135

Nyiro Gyula Korhaz, Pszihiatriai Osztaly, Budapest

1137

Processus Kft., Városkapu Rendelo, Budapest

1202

Mental Health Centre - Sofia district, Sofia

1606

Military Medical Academy, MHAT - Sofia, Sofia

2660

Dr. Kenessey Albert Korhaz-Rendelointezet 1-es Pszihiatriai Osztaly, Balassagyarmat

3000

Mental health centre - Vratsa, Vratsa

4000

Mental Health Centre - Plovdiv, Plovdiv

5700

Bekes Megyei Pandy Kalman Korhaz, Pszihiatriai Osztaly, Gyula

6500

Bajai Szent Rokus Korhaz, Neurologia/Pszichiátria, Baja

6724

Szent-Gyorgyi Albert Klinikai Kozpont, Pszichiatriai Klinika, Szeged

7623

Pecsi Tudomanyegyetem, Klinikai Kozpont, Pszich. es Pszichoter. Klinika, Pécs

9000

"Diagnostic Consultative center Tchaika", Varna

"Medical center City clinic", Varna

9024

Petz Aladar Megyei Oktato Korhaz, Pszihiatriai, Mentalhygienes es Addiktologiai Osztaly, Győr

33200

Mentoria Oy, Tampere

56014

ODESA REGIONAL MEDICAL CENTRE OF MENTAL HEALTHE DAY CARE department, Odesa

61068

Institute of Neurology, Psychiatry and Narcology, Department of Borderline and Neurotic Disorders, Kharkiv

65006

Odesa Regional Medical Centre of Mental Health Child-adolescens, Odesa

70100

Private Practice, Kuopio

73488

Kherson Regional Psychiatric Hospital, Psychiatry department, Kherson

79021

Lviv District Psychiatric hospital, Lviv

Regional Clinic of Psychiatry, Lviv

90100

Oulu Mentalcare Oy, Research Unit, Oulu

109387

Psychiatric Hospital N 13, Moscow

115522

Scientific Center of Mental Health, Dpt of Psychiatry N 1, Moscow

188820

State Budgetary lnstitution of Healthcare Leningrad RPND, In-patient psychiatry department, Roshchino

190121

Psychoneuropathology Dispensary N 10, Psychiatry dpt, Saint Petersburg

191119

City Psychiatric Hospital N 4, Psychiatric department, Saint Petersburg

192019

V.M.Bekhterev Research Institute of Psychoneurology, Department of the neuroses and psychotherapy, Saint Petersburg

344010

Scientific Center for Treatment and Rehabilitation Phoenix, Research department, Rostov-on-Don

602 00

Saint Anne s.r.o., Brno

615 00

Soukroma psychiatricka ambulance, Brno

503 41

Neuropsychiatrie HK, s.r.o., Hradec Králové

412 01

Bialbi s.r.o., Litoměřice

100 00

CLINTRIAL s.r.o., Prague

109 00

AD71 s.r.o., Prague

120 00

Pragtis s.r.o., Prague

160 00

Medical services Prague s.r.o., Prague

386 29

Psychiatricka ambulance Strakonice, Strakonice

00260

Laakarikeskus Mehilainen Psychiatric, Helsinki

820 07

Psychiatricka ambulancia Mentum, s.r.o., Bratislava

851 01

VAVRUSOVA CONSULTING s.r.o., Nestatna psychiatricka ambulancia, Bratislava

040 01

INVESTA, spol. s r.o., Psychiatricka ambulancia, Košice

024 01

Private practice, Kysucké Nové Mesto

979 01

PsychoLine psychiatricka ambulancia s.r.o., Rimavská Sobota

048 01

NsP Svatej Barbory, Psychiatricke oddelenie, Rožňava

089 01

Centrum zdravia R.B.K. s.r.o., Svidník

02660

Kyiv Municipal Psychiatric Hospital #2, Department of psychiatry, Kyiv

03049

Railway Clinic Hospital #1, Psychoneurological dpt, Kyiv

04080

"Kyiv Regional Medical Incorporation Psychiatry, Center of Novel Treatment Rehabilitation Psychotic disorders", Kyiv

Ukrainian Research Institut of Social, Forensic Psyshiatry, Department of Therapy, Kyiv

All Listed Sponsors
collaborator

ADIR Association

OTHER

lead

Institut de Recherches Internationales Servier

OTHER

NCT02805439 - Efficacy and Safety of S 47445 Versus Placebo as Adjunctive Treatment in Depressed Patients Not Fully Recovered From Depressive Symptoms With a Current Antidepressant Treatment | Biotech Hunter | Biotech Hunter