Clinical trial 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
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR Association
First posted: 2016-06-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Hamilton Depression Rating Scale (HAM-D) total score expressed as change from baseline value
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: HAM-D total score
timeFrame: at week 0, week 2, week 4, week 6 and week 8
measure: Response to treatment defined by HAM-D total score decrease from baseline ≥ 50%
timeFrame: at week 0, week 2, week 4, week 6 and week 8
measure: 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)
timeFrame: 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
measure: Hospital Anxiety and Depression Scale (HAD), Anxiety and Depression sub-scores
timeFrame: at week 0, week 2, week 4, week 6 and week 8
measure: Sheehan Disability Scale (SDS) scores (Work, social and family life)
timeFrame: at week 0, week 2, week 4, week 6 and week 8
measure: Adverse Events
timeFrame: through study completion (an average of 12 weeks)
measure: Body Weight
timeFrame: at week 4 and week 8
measure: BMI
timeFrame: at week 4 and week 8
measure: Laboratory tests (haematology and biochemistry)
timeFrame: at week 4 and week 8
measure: 12-lead ECG
timeFrame: at week 4 and week 8
measure: Vital signs (standing and supine Systolic and Diastolic Blood Pressure, heart rate)
timeFrame: at week 0, week 2, week 4, week 6 and week 8
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: at week 0, week 2, week 4, week 6 and week 8
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Mental Health Centre - Plovdiv
city: Sofia
country: Bulgaria
facility: Mental Health Centre - Sofia district
city: Sofia
country: Bulgaria
facility: Military Medical Academy, MHAT - Sofia
city: Varna
country: Bulgaria
facility: Diagnostic Consultative center "Tchaika"
city: Varna
country: Bulgaria
facility: Medical center "City clinic"
city: Vratsa
country: Bulgaria
facility: Mental health centre - Vratsa
city: Brno
country: Czechia
facility: Saint Anne s.r.o.
city: Brno
country: Czechia
facility: Soukroma psychiatricka ambulance
city: Hradec Kralove
country: Czechia
facility: Neuropsychiatrie HK, s.r.o.
city: Litomerice
country: Czechia
facility: Bialbi s.r.o.
city: Praha
country: Czechia
facility: CLINTRIAL s.r.o.
city: Praha
country: Czechia
facility: AD71 s.r.o.
city: Praha
country: Czechia
facility: Pragtis s.r.o.
city: Praha
country: Czechia
facility: Medical services Prague s.r.o.
city: Strakonice
country: Czechia
facility: Psychiatricka ambulance Strakonice
city: Helsinki
country: Finland
facility: Laakarikeskus Mehilainen Psychiatric
city: Kuopio
country: Finland
facility: Private Practice
city: Oulu
country: Finland
facility: Oulu Mentalcare Oy, Research Unit
city: Tampere
country: Finland
facility: Mentoria Oy
city: Baja
country: Hungary
facility: Bajai Szent Rokus Korhaz, Neurologia/Pszichiátria
city: Balassagyarmat
country: Hungary
facility: Dr. Kenessey Albert Korhaz-Rendelointezet 1-es Pszihiatriai Osztaly
city: Budapest
country: Hungary
facility: Forras Outpatient Clinic
city: Budapest
country: Hungary
facility: Semmelweis Orvostudomanyi Egyetem, Pszichiatriai es Pszichoterapias Klinika
city: Budapest
country: Hungary
facility: Nyiro Gyula Korhaz, Pszihiatriai Osztaly
city: Budapest
country: Hungary
facility: Processus Kft., Városkapu Rendelo
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz, Pszihiatriai, Mentalhygienes es Addiktologiai Osztaly
city: Gyula
country: Hungary
facility: Bekes Megyei Pandy Kalman Korhaz, Pszihiatriai Osztaly
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem, Klinikai Kozpont, Pszich. es Pszichoter. Klinika
city: Szeged
country: Hungary
facility: Szent-Gyorgyi Albert Klinikai Kozpont, Pszichiatriai Klinika
city: Moscow
country: Russian Federation
facility: Psychiatric Hospital N 13
city: Moscow
country: Russian Federation
facility: Scientific Center of Mental Health, Dpt of Psychiatry N 1
city: Roshchino
country: Russian Federation
facility: State Budgetary lnstitution of Healthcare Leningrad RPND, In-patient psychiatry department
city: Rostov on don
country: Russian Federation
facility: Scientific Center for Treatment and Rehabilitation Phoenix, Research department
city: St Petersburg
country: Russian Federation
facility: Psychoneuropathology Dispensary N 10, Psychiatry dpt
city: St Petersburg
country: Russian Federation
facility: City Psychiatric Hospital N 4, Psychiatric department
city: St Petersburg
country: Russian Federation
facility: V.M.Bekhterev Research Institute of Psychoneurology, Department of the neuroses and psychotherapy
city: Bratislava
country: Slovakia
facility: Psychiatricka ambulancia Mentum, s.r.o.
city: Bratislava
country: Slovakia
facility: VAVRUSOVA CONSULTING s.r.o., Nestatna psychiatricka ambulancia
city: Kosice
country: Slovakia
facility: INVESTA, spol. s r.o., Psychiatricka ambulancia
city: Kysucke Nove Mesto
country: Slovakia
facility: Private practice
city: Rimavska Sobota
country: Slovakia
facility: PsychoLine psychiatricka ambulancia s.r.o.
city: Roznava
country: Slovakia
facility: NsP Svatej Barbory, Psychiatricke oddelenie
city: Svidnik
country: Slovakia
facility: Centrum zdravia R.B.K. s.r.o.
city: Kharkiv
country: Ukraine
facility: Institute of Neurology, Psychiatry and Narcology, Department of Borderline and Neurotic Disorders
city: Kherson
country: Ukraine
facility: Kherson Regional Psychiatric Hospital, Psychiatry department
city: Kyiv
country: Ukraine
facility: Kyiv Municipal Psychiatric Hospital #2, Department of psychiatry
city: Kyiv
country: Ukraine
facility: Railway Clinic Hospital #1, Psychoneurological dpt
city: Kyiv
country: Ukraine
facility: Kyiv Regional Medical Incorporation "Psychiatry", Center of Novel Treatment Rehabilitation Psychotic disorders
city: Kyiv
country: Ukraine
facility: Ukrainian Research Institut of Social, Forensic Psyshiatry, Department of Therapy
city: Lviv
country: Ukraine
facility: Lviv District Psychiatric hospital
city: Lviv
country: Ukraine
facility: Regional Clinic of Psychiatry
city: Odesa
country: Ukraine
facility: ODESA REGIONAL MEDICAL CENTRE OF MENTAL HEALTHE DAY CARE department
city: Odesa
country: Ukraine
facility: Odesa Regional Medical Centre of Mental Health Child-adolescens
Study officials:
References: