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
Phase 2
Completed
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: S47445 50mgDrug: S47445 15mgDrug: Placebo
- Registration Number
- NCT02805439
- Lead Sponsor
- Institut de Recherches Internationales Servier
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S47445 50mg S47445 50mg - S47445 15mg S47445 15mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Hamilton Depression Rating Scale (HAM-D) total score expressed as change from baseline value 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method Adverse Events through study completion (an average of 12 weeks) Safety criterion
Laboratory tests (haematology and biochemistry) at week 4 and week 8 Safety criterion
HAM-D total score at week 0, week 2, week 4, week 6 and week 8 Depressive symptoms
BMI at week 4 and week 8 Safety criterion
Vital signs (standing and supine Systolic and Diastolic Blood Pressure, heart rate) at week 0, week 2, week 4, week 6 and week 8 Safety criterion
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 Depressive symptoms
Sheehan Disability Scale (SDS) scores (Work, social and family life) at week 0, week 2, week 4, week 6 and week 8 Social functioning
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 Depressive symptoms
Hospital Anxiety and Depression Scale (HAD), Anxiety and Depression sub-scores at week 0, week 2, week 4, week 6 and week 8 Depressive symptoms
Columbia-Suicide Severity Rating Scale (C-SSRS) at week 0, week 2, week 4, week 6 and week 8 Safety criterion
12-lead ECG at week 4 and week 8 Safety criterion
Body Weight at week 4 and week 8 Safety criterion
Trial Locations
- Locations (53)
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, Bulgaria
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
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