Major Depressive DisorderPhase 2NCT02805439
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
A Phase 2 study testing S47445 15mg and S47445 50mg in people with Major Depressive Disorder, run by Institut de Recherches Internationales Servier at 53 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- S47445 15mg and S47445 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 53 sitesin 7 countries
- Study dates
- Mar 2016to Apr 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
53 sites in 7 countries.
53 sites in 7 countries
Hungary10 sites
Bajai Szent Rokus Korhaz, Neurologia/Pszichiátria
Baja, 6500
Dr. Kenessey Albert Korhaz-Rendelointezet 1-es Pszihiatriai Osztaly
Balassagyarmat, 2660
Forras Outpatient Clinic
Budapest, 1032
Semmelweis Orvostudomanyi Egyetem, Pszichiatriai es Pszichoterapias Klinika
Budapest, 1083
Nyiro Gyula Korhaz, Pszihiatriai Osztaly
Budapest, 1135
Processus Kft., Városkapu Rendelo
Budapest, 1137
Petz Aladar Megyei Oktato Korhaz, Pszihiatriai, Mentalhygienes es Addiktologiai Osztaly
Győr, 9024
Bekes Megyei Pandy Kalman Korhaz, Pszihiatriai Osztaly
Gyula, 5700
Pecsi Tudomanyegyetem, Klinikai Kozpont, Pszich. es Pszichoter. Klinika
Pécs, 7623
Szent-Gyorgyi Albert Klinikai Kozpont, Pszichiatriai Klinika
Szeged, 6724
Ukraine10 sites
Institute of Neurology, Psychiatry and Narcology, Department of Borderline and Neurotic Disorders
Kharkiv, 61068
Kherson Regional Psychiatric Hospital, Psychiatry department
Kherson, 73488
Kyiv Municipal Psychiatric Hospital #2, Department of psychiatry
Kyiv, 02660
Railway Clinic Hospital #1, Psychoneurological dpt
Kyiv, 03049
Kyiv Regional Medical Incorporation "Psychiatry", Center of Novel Treatment Rehabilitation Psychotic disorders
Kyiv, 04080
Ukrainian Research Institut of Social, Forensic Psyshiatry, Department of Therapy
Kyiv, 04080
Lviv District Psychiatric hospital
Lviv, 79021
Regional Clinic of Psychiatry
Lviv, 79021
ODESA REGIONAL MEDICAL CENTRE OF MENTAL HEALTHE DAY CARE department
Odesa, 56014
Odesa Regional Medical Centre of Mental Health Child-adolescens
Odesa, 65006
Czechia9 sites
Saint Anne s.r.o.
Brno, 602 00
Soukroma psychiatricka ambulance
Brno, 615 00
Neuropsychiatrie HK, s.r.o.
Hradec Králové, 503 41
Bialbi s.r.o.
Litoměřice, 412 01
CLINTRIAL s.r.o.
Prague, 100 00
AD71 s.r.o.
Prague, 109 00
Pragtis s.r.o.
Prague, 120 00
Medical services Prague s.r.o.
Prague, 160 00
Psychiatricka ambulance Strakonice
Strakonice, 386 29
Russia7 sites
Psychiatric Hospital N 13
Moscow, 109387
Scientific Center of Mental Health, Dpt of Psychiatry N 1
Moscow, 115522
State Budgetary lnstitution of Healthcare Leningrad RPND, In-patient psychiatry department
Roshchino, 188820
Scientific Center for Treatment and Rehabilitation Phoenix, Research department
Rostov-on-Don, 344010
Psychoneuropathology Dispensary N 10, Psychiatry dpt
Saint Petersburg, 190121
City Psychiatric Hospital N 4, Psychiatric department
Saint Petersburg, 191119
V.M.Bekhterev Research Institute of Psychoneurology, Department of the neuroses and psychotherapy
Saint Petersburg, 192019
Slovakia7 sites
Psychiatricka ambulancia Mentum, s.r.o.
Bratislava, 820 07
VAVRUSOVA CONSULTING s.r.o., Nestatna psychiatricka ambulancia
Bratislava, 851 01
INVESTA, spol. s r.o., Psychiatricka ambulancia
Košice, 040 01
Private practice
Kysucké Nové Mesto, 024 01
PsychoLine psychiatricka ambulancia s.r.o.
Rimavská Sobota, 979 01
NsP Svatej Barbory, Psychiatricke oddelenie
Rožňava, 048 01
Centrum zdravia R.B.K. s.r.o.
Svidník, 089 01
Bulgaria6 sites
Mental Health Centre - Plovdiv
Plovdiv, 4000
Mental Health Centre - Sofia district
Sofia, 1202
Military Medical Academy, MHAT - Sofia
Sofia, 1606
Diagnostic Consultative center "Tchaika"
Varna, 9000
Medical center "City clinic"
Varna, 9000
Mental health centre - Vratsa
Vratsa, 3000
Finland4 sites
Laakarikeskus Mehilainen Psychiatric
Helsinki, 00260
Private Practice
Kuopio, 70100
Oulu Mentalcare Oy, Research Unit
Oulu, 90100
Mentoria Oy
Tampere, 33200
About this study
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
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
- Being tested
- S47445 15mg, S47445 50mg, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S47445 15mgDrug
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 50mgDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| S47445 15mg | Experimental | Not described Receives: Drug: S47445 15mg |
| S47445 50mg | Experimental | Not described Receives: Drug: S47445 50mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAM-D) total score expressed as change from baseline value
Measured: 8 weeks of treatment
Secondary outcomes (12)
HAM-D total score
Depressive symptoms
Measured: 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%
Depressive symptoms
Measured: 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)
Depressive symptoms
Measured: 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
Depressive symptoms
Measured: at week 0, week 2, week 4, week 6 and week 8
Sheehan Disability Scale (SDS) scores (Work, social and family life)
Social functioning
Measured: at week 0, week 2, week 4, week 6 and week 8
Adverse Events
Safety criterion
Measured: through study completion (an average of 12 weeks)
Body Weight
Safety criterion
Measured: at week 4 and week 8
BMI
Safety criterion
Measured: at week 4 and week 8
Laboratory tests (haematology and biochemistry)
Safety criterion
Measured: at week 4 and week 8
12-lead ECG
Safety criterion
Measured: at week 4 and week 8
Vital signs (standing and supine Systolic and Diastolic Blood Pressure, heart rate)
Safety criterion
Measured: at week 0, week 2, week 4, week 6 and week 8
Columbia-Suicide Severity Rating Scale (C-SSRS)
Safety criterion
Measured: at week 0, week 2, week 4, week 6 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805439
- Sponsor's protocol ID
- CL2-47445-014
- Other IDs
- 2015-003867-13, 2015
- Status last verified
- Jan 2020
- First submitted
- 13 Jun 2016
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02805439
- Acronym / sponsor ID
- CL2-47445-014
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- ADIR Association
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| S47445 15mg | Experimental | Drug: S47445 15mg |
| S47445 50mg | Experimental | Drug: S47445 50mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S47445 15mgOne 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. | Drug | S47445 15mg |
| S47445 50mgOne 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. | Drug | S47445 50mg |
| PlaceboOne 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. | Drug | Placebo |
Primary outcome
Hamilton Depression Rating Scale (HAM-D) total score expressed as change from baseline value
Time frame: 8 weeks of treatment
12 secondary outcomes
HAM-D total score
Time frame: 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%
Time frame: 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)
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
Hospital Anxiety and Depression Scale (HAD), Anxiety and Depression sub-scores
Time frame: at week 0, week 2, week 4, week 6 and week 8
Sheehan Disability Scale (SDS) scores (Work, social and family life)
Time frame: at week 0, week 2, week 4, week 6 and week 8
Adverse Events
Time frame: through study completion (an average of 12 weeks)
Body Weight
Time frame: at week 4 and week 8
BMI
Time frame: at week 4 and week 8
Laboratory tests (haematology and biochemistry)
Time frame: at week 4 and week 8
12-lead ECG
Time frame: at week 4 and week 8
Vital signs (standing and supine Systolic and Diastolic Blood Pressure, heart rate)
Time frame: at week 0, week 2, week 4, week 6 and week 8
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: at week 0, week 2, week 4, week 6 and week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S47445 15mg and S47445 50mg in people with Major Depressive Disorder, run by Institut de Recherches Internationales Servier at 53 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Hungary, Ukraine, Czechia, Russia, Slovakia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HAM-D) total score expressed as change from baseline value (time frame: 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.