Back to resultsEfficacy and Safety of S 47445 Versus Placebo as Adjunctive Treatment in Depressed Patients Not Fully Recovered From Depressive Symptoms With a Current Antidepressant Treatment
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
S47445 15mg
S47445 50mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Mental Health Centre - Plovdiv
- Mental Health Centre - Sofia district
- Military Medical Academy, MHAT - Sofia
- Diagnostic Consultative center "Tchaika"
- Medical center "City clinic"
- Mental health centre - Vratsa
- Saint Anne s.r.o.
- Soukroma psychiatricka ambulance
- Neuropsychiatrie HK, s.r.o.
- Bialbi s.r.o.
- CLINTRIAL s.r.o.
- AD71 s.r.o.
- Pragtis s.r.o.
- Medical services Prague s.r.o.
- Psychiatricka ambulance Strakonice
- Laakarikeskus Mehilainen Psychiatric
- Private Practice
- Oulu Mentalcare Oy, Research Unit
- Mentoria Oy
- Bajai Szent Rokus Korhaz, Neurologia/Pszichiátria
- Dr. Kenessey Albert Korhaz-Rendelointezet 1-es Pszihiatriai Osztaly
- Forras Outpatient Clinic
- Semmelweis Orvostudomanyi Egyetem, Pszichiatriai es Pszichoterapias Klinika
- Nyiro Gyula Korhaz, Pszihiatriai Osztaly
- Processus Kft., Városkapu Rendelo
- Petz Aladar Megyei Oktato Korhaz, Pszihiatriai, Mentalhygienes es Addiktologiai Osztaly
- Bekes Megyei Pandy Kalman Korhaz, Pszihiatriai Osztaly
- Pecsi Tudomanyegyetem, Klinikai Kozpont, Pszich. es Pszichoter. Klinika
- Szent-Gyorgyi Albert Klinikai Kozpont, Pszichiatriai Klinika
- Psychiatric Hospital N 13
- Scientific Center of Mental Health, Dpt of Psychiatry N 1
- State Budgetary lnstitution of Healthcare Leningrad RPND, In-patient psychiatry department
- Scientific Center for Treatment and Rehabilitation Phoenix, Research department
- Psychoneuropathology Dispensary N 10, Psychiatry dpt
- City Psychiatric Hospital N 4, Psychiatric department
- V.M.Bekhterev Research Institute of Psychoneurology, Department of the neuroses and psychotherapy
- Psychiatricka ambulancia Mentum, s.r.o.
- VAVRUSOVA CONSULTING s.r.o., Nestatna psychiatricka ambulancia
- INVESTA, spol. s r.o., Psychiatricka ambulancia
- Private practice
- PsychoLine psychiatricka ambulancia s.r.o.
- NsP Svatej Barbory, Psychiatricke oddelenie
- Centrum zdravia R.B.K. s.r.o.
- Institute of Neurology, Psychiatry and Narcology, Department of Borderline and Neurotic Disorders
- Kherson Regional Psychiatric Hospital, Psychiatry department
- Kyiv Municipal Psychiatric Hospital #2, Department of psychiatry
- Railway Clinic Hospital #1, Psychoneurological dpt
- Kyiv Regional Medical Incorporation "Psychiatry", Center of Novel Treatment Rehabilitation Psychotic disorders
- Ukrainian Research Institut of Social, Forensic Psyshiatry, Department of Therapy
- Lviv District Psychiatric hospital
- Regional Clinic of Psychiatry
- ODESA REGIONAL MEDICAL CENTRE OF MENTAL HEALTHE DAY CARE department
- Odesa Regional Medical Centre of Mental Health Child-adolescens
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
S47445 15mg
S47445 50mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale (HAM-D) total score expressed as change from baseline value
Secondary Outcome Measures
HAM-D total score
Depressive symptoms
Response to treatment defined by HAM-D total score decrease from baseline ≥ 50%
Depressive symptoms
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)
Depressive symptoms
Hospital Anxiety and Depression Scale (HAD), Anxiety and Depression sub-scores
Depressive symptoms
Sheehan Disability Scale (SDS) scores (Work, social and family life)
Social functioning
Adverse Events
Safety criterion
Body Weight
Safety criterion
BMI
Safety criterion
Laboratory tests (haematology and biochemistry)
Safety criterion
12-lead ECG
Safety criterion
Vital signs (standing and supine Systolic and Diastolic Blood Pressure, heart rate)
Safety criterion
Columbia-Suicide Severity Rating Scale (C-SSRS)
Safety criterion
Full Information
NCT ID
NCT02805439
First Posted
June 13, 2016
Last Updated
January 2, 2020
Sponsor
Institut de Recherches Internationales Servier
Collaborators
ADIR Association
1. Study Identification
Unique Protocol Identification Number
NCT02805439
Brief Title
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
Official Title
Efficacy and Safety of S 47445 Versus Placebo as Adjunctive Treatment of Major Depressive Disorder in Patients With an Inadequate Response to Antidepressant Therapy: A Randomised, Double-blind, Placebo Controlled International, Multicentre Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Internationales Servier
Collaborators
ADIR Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S47445 15mg
Arm Type
Experimental
Arm Title
S47445 50mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
S47445 15mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
S47445 50mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HAM-D) total score expressed as change from baseline value
Time Frame
8 weeks of treatment
Secondary Outcome Measure Information:
Title
HAM-D total score
Description
Depressive symptoms
Time Frame
at week 0, week 2, week 4, week 6 and week 8
Title
Response to treatment defined by HAM-D total score decrease from baseline ≥ 50%
Description
Depressive symptoms
Time Frame
at week 0, week 2, week 4, week 6 and week 8
Title
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)
Description
Depressive symptoms
Time Frame
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
Title
Hospital Anxiety and Depression Scale (HAD), Anxiety and Depression sub-scores
Description
Depressive symptoms
Time Frame
at week 0, week 2, week 4, week 6 and week 8
Title
Sheehan Disability Scale (SDS) scores (Work, social and family life)
Description
Social functioning
Time Frame
at week 0, week 2, week 4, week 6 and week 8
Title
Adverse Events
Description
Safety criterion
Time Frame
through study completion (an average of 12 weeks)
Title
Body Weight
Description
Safety criterion
Time Frame
at week 4 and week 8
Title
BMI
Description
Safety criterion
Time Frame
at week 4 and week 8
Title
Laboratory tests (haematology and biochemistry)
Description
Safety criterion
Time Frame
at week 4 and week 8
Title
12-lead ECG
Description
Safety criterion
Time Frame
at week 4 and week 8
Title
Vital signs (standing and supine Systolic and Diastolic Blood Pressure, heart rate)
Description
Safety criterion
Time Frame
at week 0, week 2, week 4, week 6 and week 8
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
Safety criterion
Time Frame
at week 0, week 2, week 4, week 6 and week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Facility Information:
Facility Name
Mental Health Centre - Plovdiv
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Mental Health Centre - Sofia district
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Military Medical Academy, MHAT - Sofia
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Diagnostic Consultative center "Tchaika"
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Medical center "City clinic"
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Mental health centre - Vratsa
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Saint Anne s.r.o.
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Soukroma psychiatricka ambulance
City
Brno
ZIP/Postal Code
615 00
Country
Czechia
Facility Name
Neuropsychiatrie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
503 41
Country
Czechia
Facility Name
Bialbi s.r.o.
City
Litomerice
ZIP/Postal Code
412 01
Country
Czechia
Facility Name
CLINTRIAL s.r.o.
City
Praha
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
AD71 s.r.o.
City
Praha
ZIP/Postal Code
109 00
Country
Czechia
Facility Name
Pragtis s.r.o.
City
Praha
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Medical services Prague s.r.o.
City
Praha
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Psychiatricka ambulance Strakonice
City
Strakonice
ZIP/Postal Code
386 29
Country
Czechia
Facility Name
Laakarikeskus Mehilainen Psychiatric
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
Facility Name
Private Practice
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Oulu Mentalcare Oy, Research Unit
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Mentoria Oy
City
Tampere
ZIP/Postal Code
33200
Country
Finland
Facility Name
Bajai Szent Rokus Korhaz, Neurologia/Pszichiátria
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Dr. Kenessey Albert Korhaz-Rendelointezet 1-es Pszihiatriai Osztaly
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Forras Outpatient Clinic
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Semmelweis Orvostudomanyi Egyetem, Pszichiatriai es Pszichoterapias Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Nyiro Gyula Korhaz, Pszihiatriai Osztaly
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Processus Kft., Városkapu Rendelo
City
Budapest
ZIP/Postal Code
1137
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz, Pszihiatriai, Mentalhygienes es Addiktologiai Osztaly
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Bekes Megyei Pandy Kalman Korhaz, Pszihiatriai Osztaly
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem, Klinikai Kozpont, Pszich. es Pszichoter. Klinika
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Szent-Gyorgyi Albert Klinikai Kozpont, Pszichiatriai Klinika
City
Szeged
ZIP/Postal Code
6724
Country
Hungary
Facility Name
Psychiatric Hospital N 13
City
Moscow
ZIP/Postal Code
109387
Country
Russian Federation
Facility Name
Scientific Center of Mental Health, Dpt of Psychiatry N 1
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
State Budgetary lnstitution of Healthcare Leningrad RPND, In-patient psychiatry department
City
Roshchino
ZIP/Postal Code
188820
Country
Russian Federation
Facility Name
Scientific Center for Treatment and Rehabilitation Phoenix, Research department
City
Rostov on don
ZIP/Postal Code
344010
Country
Russian Federation
Facility Name
Psychoneuropathology Dispensary N 10, Psychiatry dpt
City
St Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
City Psychiatric Hospital N 4, Psychiatric department
City
St Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
V.M.Bekhterev Research Institute of Psychoneurology, Department of the neuroses and psychotherapy
City
St Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Psychiatricka ambulancia Mentum, s.r.o.
City
Bratislava
ZIP/Postal Code
820 07
Country
Slovakia
Facility Name
VAVRUSOVA CONSULTING s.r.o., Nestatna psychiatricka ambulancia
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
Facility Name
INVESTA, spol. s r.o., Psychiatricka ambulancia
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Private practice
City
Kysucke Nove Mesto
ZIP/Postal Code
024 01
Country
Slovakia
Facility Name
PsychoLine psychiatricka ambulancia s.r.o.
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
NsP Svatej Barbory, Psychiatricke oddelenie
City
Roznava
ZIP/Postal Code
048 01
Country
Slovakia
Facility Name
Centrum zdravia R.B.K. s.r.o.
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
Institute of Neurology, Psychiatry and Narcology, Department of Borderline and Neurotic Disorders
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kherson Regional Psychiatric Hospital, Psychiatry department
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Kyiv Municipal Psychiatric Hospital #2, Department of psychiatry
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Railway Clinic Hospital #1, Psychoneurological dpt
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Kyiv Regional Medical Incorporation "Psychiatry", Center of Novel Treatment Rehabilitation Psychotic disorders
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Ukrainian Research Institut of Social, Forensic Psyshiatry, Department of Therapy
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Lviv District Psychiatric hospital
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Regional Clinic of Psychiatry
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
ODESA REGIONAL MEDICAL CENTRE OF MENTAL HEALTHE DAY CARE department
City
Odesa
ZIP/Postal Code
56014
Country
Ukraine
Facility Name
Odesa Regional Medical Centre of Mental Health Child-adolescens
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).
They can ask all interventional clinical studies:
submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
IPD Sharing Time Frame
After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD Sharing 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.
IPD Sharing URL
https://clinicaltrials.servier.com/
Links:
URL
https://clinicaltrials.servier.com/wp-content/uploads/CL2-47445-014-synopsis-report.pdf
Description
Results summary
Learn more about this trial
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
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