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
NCT ID: NCT02805439
Last Updated: 2020-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
400 participants
INTERVENTIONAL
2016-03-31
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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S47445 15mg
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.
S47445 50mg
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.
Placebo
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Fulfilling DSM-5 criteria for Major Depressive Disorder confirmed by the brief structured interview M.I.N.I. (single or recurrent episode, current episode ≤ 12 months, current depressive episode of moderate or severe intensity, with or without anxious distress, with or without melancholic features, without mixed features or atypical features, without seasonal pattern, without psychotic features, without catatonic features, without peripartum onset for the current episode)
* Patients treated for the current depressive episode with an antidepressant treatment with SSRI (fluoxetine, citalopram, paroxetine, escitalopram or sertraline) given in monotherapy at recommended dose for at least 6 weeks and no more than 4 months and with a stable dosage for at least 3 weeks
* HAM-D total score ≥ 20
* Clinical Global Impression Severity of illness (item 1): 6 ≥ CGI-S ≥ 4
* Antidepressant Treatment Response Questionnaire (ATQR) \< 50% for the current SSRI
* Absence of any abnormalities likely to interfere with the conduct of the study (ECG, vital signs, laboratory tests, medical history)
Exclusion Criteria
* All types of depressive episodes other than those occurring in a Major Depressive Disorder (Persistent Depressive Disorder (Dysthymia) according to DSM-5 criteria, including persistent depressive disorder with intermittent or persistent major depressive episode according to DSM-5, Premenstrual Dysphoric Disorder, Substance Induced Depressive Disorder, Depressive Disorder due to another Medical Condition, Other Specified or Unspecified Depressive Disorder, Bipolar Disorder I or II, depressed episode, Schizoaffective Disorder (Depressive or Bipolar type))
* Depression onset within 12 months after a stroke
* Suicidal risk defined as a score \> 3 on the item 3 of the HAM-D scale or in the investigator's opinion
* Lactose intolerance
* Patients with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Resistant depression for the current episode (patients who have not responded to 1 previous antidepressant treatment before the SSRI taken at an appropriate dose)
* Current panic disorder
* Obsessive compulsive disorder
* Current post traumatic stress disorder, current acute stress disorder
* Current or past psychotic disorder
* Any severe personality features
18 Years
65 Years
ALL
No
Sponsors
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ADIR Association
OTHER
Institut de Recherches Internationales Servier
OTHER
Responsible Party
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Locations
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Mental Health Centre - Plovdiv
Plovdiv, , Bulgaria
Mental Health Centre - Sofia district
Sofia, , Bulgaria
Military Medical Academy, MHAT - Sofia
Sofia, , Bulgaria
Diagnostic Consultative center "Tchaika"
Varna, , Bulgaria
Medical center "City clinic"
Varna, , Bulgaria
Mental health centre - Vratsa
Vratsa, , Bulgaria
Saint Anne s.r.o.
Brno, , Czechia
Soukroma psychiatricka ambulance
Brno, , Czechia
Neuropsychiatrie HK, s.r.o.
Hradec Králové, , Czechia
Bialbi s.r.o.
Litoměřice, , Czechia
CLINTRIAL s.r.o.
Prague, , Czechia
AD71 s.r.o.
Prague, , Czechia
Pragtis s.r.o.
Prague, , Czechia
Medical services Prague s.r.o.
Prague, , Czechia
Psychiatricka ambulance Strakonice
Strakonice, , Czechia
Laakarikeskus Mehilainen Psychiatric
Helsinki, , Finland
Private Practice
Kuopio, , Finland
Oulu Mentalcare Oy, Research Unit
Oulu, , Finland
Mentoria Oy
Tampere, , Finland
Bajai Szent Rokus Korhaz, Neurologia/Pszichiátria
Baja, , Hungary
Dr. Kenessey Albert Korhaz-Rendelointezet 1-es Pszihiatriai Osztaly
Balassagyarmat, , Hungary
Forras Outpatient Clinic
Budapest, , Hungary
Semmelweis Orvostudomanyi Egyetem, Pszichiatriai es Pszichoterapias Klinika
Budapest, , Hungary
Nyiro Gyula Korhaz, Pszihiatriai Osztaly
Budapest, , Hungary
Processus Kft., Városkapu Rendelo
Budapest, , Hungary
Petz Aladar Megyei Oktato Korhaz, Pszihiatriai, Mentalhygienes es Addiktologiai Osztaly
Győr, , Hungary
Bekes Megyei Pandy Kalman Korhaz, Pszihiatriai Osztaly
Gyula, , Hungary
Pecsi Tudomanyegyetem, Klinikai Kozpont, Pszich. es Pszichoter. Klinika
Pécs, , Hungary
Szent-Gyorgyi Albert Klinikai Kozpont, Pszichiatriai Klinika
Szeged, , Hungary
Psychiatric Hospital N 13
Moscow, , Russia
Scientific Center of Mental Health, Dpt of Psychiatry N 1
Moscow, , Russia
State Budgetary lnstitution of Healthcare Leningrad RPND, In-patient psychiatry department
Roshchino, , Russia
Scientific Center for Treatment and Rehabilitation Phoenix, Research department
Rostov-on-Don, , Russia
Psychoneuropathology Dispensary N 10, Psychiatry dpt
Saint Petersburg, , Russia
City Psychiatric Hospital N 4, Psychiatric department
Saint Petersburg, , Russia
V.M.Bekhterev Research Institute of Psychoneurology, Department of the neuroses and psychotherapy
Saint Petersburg, , Russia
Psychiatricka ambulancia Mentum, s.r.o.
Bratislava, , Slovakia
VAVRUSOVA CONSULTING s.r.o., Nestatna psychiatricka ambulancia
Bratislava, , Slovakia
INVESTA, spol. s r.o., Psychiatricka ambulancia
Košice, , Slovakia
Private practice
Kysucké Nové Mesto, , Slovakia
PsychoLine psychiatricka ambulancia s.r.o.
Rimavská Sobota, , Slovakia
NsP Svatej Barbory, Psychiatricke oddelenie
Rožňava, , Slovakia
Centrum zdravia R.B.K. s.r.o.
Svidník, , Slovakia
Institute of Neurology, Psychiatry and Narcology, Department of Borderline and Neurotic Disorders
Kharkiv, , Ukraine
Kherson Regional Psychiatric Hospital, Psychiatry department
Kherson, , Ukraine
Kyiv Municipal Psychiatric Hospital #2, Department of psychiatry
Kyiv, , Ukraine
Railway Clinic Hospital #1, Psychoneurological dpt
Kyiv, , Ukraine
Kyiv Regional Medical Incorporation "Psychiatry", Center of Novel Treatment Rehabilitation Psychotic disorders
Kyiv, , Ukraine
Ukrainian Research Institut of Social, Forensic Psyshiatry, Department of Therapy
Kyiv, , Ukraine
Lviv District Psychiatric hospital
Lviv, , Ukraine
Regional Clinic of Psychiatry
Lviv, , Ukraine
ODESA REGIONAL MEDICAL CENTRE OF MENTAL HEALTHE DAY CARE department
Odesa, , Ukraine
Odesa Regional Medical Centre of Mental Health Child-adolescens
Odesa, , Ukraine
Countries
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Other Identifiers
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2015-003867-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CL2-47445-014
Identifier Type: -
Identifier Source: org_study_id
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