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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805439
• Other study ID #: CL2-47445-014
• Secondary ID: 2015-003867-13
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: April 2017

Study information

• Verified date: January 2020
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Bulgaria	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
Czechia	Saint Anne s.r.o.	Brno
Czechia	Soukroma psychiatricka ambulance	Brno
Czechia	Neuropsychiatrie HK, s.r.o.	Hradec Kralove
Czechia	Bialbi s.r.o.	Litomerice
Czechia	AD71 s.r.o.	Praha
Czechia	CLINTRIAL s.r.o.	Praha
Czechia	Medical services Prague s.r.o.	Praha
Czechia	Pragtis s.r.o.	Praha
Czechia	Psychiatricka ambulance Strakonice	Strakonice
Finland	Laakarikeskus Mehilainen Psychiatric	Helsinki
Finland	Private Practice	Kuopio
Finland	Oulu Mentalcare Oy, Research Unit	Oulu
Finland	Mentoria Oy	Tampere
Hungary	Bajai Szent Rokus Korhaz, Neurologia/Pszichiátria	Baja
Hungary	Dr. Kenessey Albert Korhaz-Rendelointezet 1-es Pszihiatriai Osztaly	Balassagyarmat
Hungary	Forras Outpatient Clinic	Budapest
Hungary	Nyiro Gyula Korhaz, Pszihiatriai Osztaly	Budapest
Hungary	Processus Kft., Városkapu Rendelo	Budapest
Hungary	Semmelweis Orvostudomanyi Egyetem, Pszichiatriai es Pszichoterapias Klinika	Budapest
Hungary	Petz Aladar Megyei Oktato Korhaz, Pszihiatriai, Mentalhygienes es Addiktologiai Osztaly	Gyor
Hungary	Bekes Megyei Pandy Kalman Korhaz, Pszihiatriai Osztaly	Gyula
Hungary	Pecsi Tudomanyegyetem, Klinikai Kozpont, Pszich. es Pszichoter. Klinika	Pecs
Hungary	Szent-Gyorgyi Albert Klinikai Kozpont, Pszichiatriai Klinika	Szeged
Russian Federation	Psychiatric Hospital N 13	Moscow
Russian Federation	Scientific Center of Mental Health, Dpt of Psychiatry N 1	Moscow
Russian Federation	State Budgetary lnstitution of Healthcare Leningrad RPND, In-patient psychiatry department	Roshchino
Russian Federation	Scientific Center for Treatment and Rehabilitation Phoenix, Research department	Rostov on don
Russian Federation	City Psychiatric Hospital N 4, Psychiatric department	St Petersburg
Russian Federation	Psychoneuropathology Dispensary N 10, Psychiatry dpt	St Petersburg
Russian Federation	V.M.Bekhterev Research Institute of Psychoneurology, Department of the neuroses and psychotherapy	St Petersburg
Slovakia	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	Kosice
Slovakia	Private practice	Kysucke Nove Mesto
Slovakia	PsychoLine psychiatricka ambulancia s.r.o.	Rimavska Sobota
Slovakia	NsP Svatej Barbory, Psychiatricke oddelenie	Roznava
Slovakia	Centrum zdravia R.B.K. s.r.o.	Svidnik
Ukraine	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	Kyiv Regional Medical Incorporation "Psychiatry", Center of Novel Treatment Rehabilitation Psychotic disorders	Kyiv
Ukraine	Railway Clinic Hospital #1, Psychoneurological dpt	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 Health Child-adolescens	Odesa
Ukraine	ODESA REGIONAL MEDICAL CENTRE OF MENTAL HEALTHE DAY CARE department	Odesa

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	ADIR Association

Countries where clinical trial is conducted

Bulgaria,  Czechia,  Finland,  Hungary,  Russian Federation,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HAM-D) total score expressed as change from baseline value		8 weeks of treatment
Secondary	HAM-D total score	Depressive symptoms	at week 0, week 2, week 4, week 6 and week 8
Secondary	Response to treatment defined by HAM-D total score decrease from baseline = 50%	Depressive symptoms	at week 0, week 2, week 4, week 6 and week 8
Secondary	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	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
Secondary	Hospital Anxiety and Depression Scale (HAD), Anxiety and Depression sub-scores	Depressive symptoms	at week 0, week 2, week 4, week 6 and week 8
Secondary	Sheehan Disability Scale (SDS) scores (Work, social and family life)	Social functioning	at week 0, week 2, week 4, week 6 and week 8
Secondary	Adverse Events	Safety criterion	through study completion (an average of 12 weeks)
Secondary	Body Weight	Safety criterion	at week 4 and week 8
Secondary	BMI	Safety criterion	at week 4 and week 8
Secondary	Laboratory tests (haematology and biochemistry)	Safety criterion	at week 4 and week 8
Secondary	12-lead ECG	Safety criterion	at week 4 and week 8
Secondary	Vital signs (standing and supine Systolic and Diastolic Blood Pressure, heart rate)	Safety criterion	at week 0, week 2, week 4, week 6 and week 8
Secondary	Columbia-Suicide Severity Rating Scale (C-SSRS)	Safety criterion	at week 0, week 2, week 4, week 6 and week 8

External Links

•   Results summary