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

NCT02805439 | Completed Phase 2

• 2 other identifiers: CL2-47445-0142015-003867-13
• Study Type: interventional
• Target: 400
• Locations: 7 countries
• Sites: 53

Brief Summary

The purpose of this study is to assess the efficacy and safety of S47445 versus placebo as adjunctive treatment of Major Depressive Disorder in patients with an inadequate response to antidepressant therapy.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HAM-D) total score expressed as change from baseline value

  8 weeks of treatment

Secondary Outcomes (12)

• HAM-D total score

  at week 0, week 2, week 4, week 6 and week 8

• Response to treatment defined by HAM-D total score decrease from baseline ≥ 50%

  at week 0, week 2, week 4, week 6 and week 8

• Clinical Global Impression scale (CGI), item 1 (Severity of depression) and item 2 (global Improvement) scores, response to treatment (CGI item 2 = 1 or 2)

  CGI item 1 at week 0, week 2, week 4, week 6 and week 8 and item 2 at week 2, week 4, week 6 and week 8

• Hospital Anxiety and Depression Scale (HAD), Anxiety and Depression sub-scores

  at week 0, week 2, week 4, week 6 and week 8

• Sheehan Disability Scale (SDS) scores (Work, social and family life)

  at week 0, week 2, week 4, week 6 and week 8

Study Arms (3)

S47445 15mg

EXPERIMENTAL

Drug: S47445 15mg

S47445 50mg

EXPERIMENTAL

Drug: S47445 50mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

S47445 15mg DRUG

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 15mg

S47445 50mg DRUG

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.

S47445 50mg

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients
• 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)

You may not qualify if:

• Depressive episode of mild intensity according to DSM-5 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

Sponsors & Collaborators

• Institut de Recherches Internationales Servier: lead
• ADIR Association: collaborator

Study Sites (53)

Mental Health Centre - Plovdiv

Plovdiv, 4000, Bulgaria

Location

Mental Health Centre - Sofia district

Sofia, 1202, Bulgaria

Location

Military Medical Academy, MHAT - Sofia

Sofia, 1606, Bulgaria

Location

Diagnostic Consultative center "Tchaika"

Varna, 9000, Bulgaria

Location

Medical center "City clinic"

Varna, 9000, Bulgaria

Location

Mental health centre - Vratsa

Vratsa, 3000, Bulgaria

Location

Saint Anne s.r.o.

Brno, 602 00, Czechia

Location

Soukroma psychiatricka ambulance

Brno, 615 00, Czechia

Location

Neuropsychiatrie HK, s.r.o.

Hradec Králové, 503 41, Czechia

Location

Bialbi s.r.o.

Litoměřice, 412 01, Czechia

Location

CLINTRIAL s.r.o.

Prague, 100 00, Czechia

Location

AD71 s.r.o.

Prague, 109 00, Czechia

Location

Pragtis s.r.o.

Prague, 120 00, Czechia

Location

Medical services Prague s.r.o.

Prague, 160 00, Czechia

Location

Psychiatricka ambulance Strakonice

Strakonice, 386 29, Czechia

Location

Laakarikeskus Mehilainen Psychiatric

Helsinki, 00260, Finland

Location

Private Practice

Kuopio, 70100, Finland

Location

Oulu Mentalcare Oy, Research Unit

Oulu, 90100, Finland

Location

Mentoria Oy

Tampere, 33200, Finland

Location

Bajai Szent Rokus Korhaz, Neurologia/Pszichiátria

Baja, 6500, Hungary

Location

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

Balassagyarmat, 2660, Hungary

Location

Forras Outpatient Clinic

Budapest, 1032, Hungary

Location

Semmelweis Orvostudomanyi Egyetem, Pszichiatriai es Pszichoterapias Klinika

Budapest, 1083, Hungary

Location

Nyiro Gyula Korhaz, Pszihiatriai Osztaly

Budapest, 1135, Hungary

Location

Processus Kft., Városkapu Rendelo

Budapest, 1137, Hungary

Location

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

Győr, 9024, Hungary

Location

Bekes Megyei Pandy Kalman Korhaz, Pszihiatriai Osztaly

Gyula, 5700, Hungary

Location

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

Pécs, 7623, Hungary

Location

Szent-Gyorgyi Albert Klinikai Kozpont, Pszichiatriai Klinika

Szeged, 6724, Hungary

Location

Psychiatric Hospital N 13

Moscow, 109387, Russia

Location

Scientific Center of Mental Health, Dpt of Psychiatry N 1

Moscow, 115522, Russia

Location

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

Roshchino, 188820, Russia

Location

Scientific Center for Treatment and Rehabilitation Phoenix, Research department

Rostov-on-Don, 344010, Russia

Location

Psychoneuropathology Dispensary N 10, Psychiatry dpt

Saint Petersburg, 190121, Russia

Location

City Psychiatric Hospital N 4, Psychiatric department

Saint Petersburg, 191119, Russia

Location

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

Saint Petersburg, 192019, Russia

Location

Psychiatricka ambulancia Mentum, s.r.o.

Bratislava, 820 07, Slovakia

Location

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

Bratislava, 851 01, Slovakia

Location

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

Košice, 040 01, Slovakia

Location

Private practice

Kysucké Nové Mesto, 024 01, Slovakia

Location

PsychoLine psychiatricka ambulancia s.r.o.

Rimavská Sobota, 979 01, Slovakia

Location

NsP Svatej Barbory, Psychiatricke oddelenie

Rožňava, 048 01, Slovakia

Location

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

Svidník, 089 01, Slovakia

Location

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

Kharkiv, 61068, Ukraine

Location

Kherson Regional Psychiatric Hospital, Psychiatry department

Kherson, 73488, Ukraine

Location

Kyiv Municipal Psychiatric Hospital #2, Department of psychiatry

Kyiv, 02660, Ukraine

Location

Railway Clinic Hospital #1, Psychoneurological dpt

Kyiv, 03049, Ukraine

Location

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

Kyiv, 04080, Ukraine

Location

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

Kyiv, 04080, Ukraine

Location

Lviv District Psychiatric hospital

Lviv, 79021, Ukraine

Location

Regional Clinic of Psychiatry

Lviv, 79021, Ukraine

Location

ODESA REGIONAL MEDICAL CENTRE OF MENTAL HEALTHE DAY CARE department

Odesa, 56014, Ukraine

Location

Odesa Regional Medical Centre of Mental Health Child-adolescens

Odesa, 65006, Ukraine

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 20, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: January 3, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

Locations

BU (6); CZ (9); RU (7); HU (10); SL (7); UA (10); FI (4)