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.

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003867-13-HU

Enrollment

400

Registered

2015-12-21

Start date

2016-02-15

Completion date

Unknown

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder MedDRA version: 19.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: S47445 Product Code: S47445 Pharmaceutical Form: Film-coated tablet Current Sponsor code: S47445 Other descriptive name: S47445 Concentration unit: mg milligram(s) Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Outpatients - Male or female aged between 18 (or legal age of majority in the country) and 65 years (inclusive), - 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) =65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: - Assessment of the response defined by the HAM-D total score decrease from baseline = 50% - Assessment of the efficacy of the two doses of S 47445 as compared to placebo on Global improvement and social functioning using Clinical Global Impression (CGI), Hospital Anxiety and Depression scale (HAD) and Sheehan Disability Scale (SDS) - Assessment of the safety and the tolerance of the two doses of S 47445 compared to placebo - Evaluation of the pharmacokinetics of S 47445 after repeated oral administration;Primary end point(s): HAM-D total score expressed as change from baseline value ;Timepoint(s) of evaluation of this end point: At W0, W2, W4, W6 and W8;Main Objective: Assessment of the efficacy of the two doses of S 47445 (15mg/day and 50mg/day) of S 47445 compared to placebo after a 8-week treatment period using the Hamilton Depression Rating Scale 17 items (HAM-D)	—

Measure

Time frame

Secondary Objective: - Assessment of the response defined by the HAM-D total score decrease from baseline = 50% - Assessment of the efficacy of the two doses of S 47445 as compared to placebo on Global improvement and social functioning using Clinical Global Impression (CGI), Hospital Anxiety and Depression scale (HAD) and Sheehan Disability Scale (SDS) - Assessment of the safety and the tolerance of the two doses of S 47445 compared to placebo - Evaluation of the pharmacokinetics of S 47445 after repeated oral administration;Primary end point(s): HAM-D total score expressed as change from baseline value ;Timepoint(s) of evaluation of this end point: At W0, W2, W4, W6 and W8;Main Objective: Assessment of the efficacy of the two doses of S 47445 (15mg/day and 50mg/day) of S 47445 compared to placebo after a 8-week treatment period using the Hamilton Depression Rating Scale 17 items (HAM-D)

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Secondary

Measure	Time frame
Secondary end point(s): Depressive symptoms: - HAM-D total score at each visit, - Response to treatment defined by HAM-D total score decrease from baseline = 50% - Clinical Global Impression scale (CGI), item 1 (Severity of depression) and item 2 (global Improvement) scores, response to treatment (CGI item 2 = 1or 2) - Hospital Anxiety and Depression Scale (HAD), Anxiety and Depression sub-scores Social functioning - Sheehan Disability Scale (SDS) scores (Work, social and family life) Safety criteria: - Adverse Events - Body Weight and BMI - Laboratory tests (haematology and biochemistry) - 12-lead ECG - Vital signs (standing and supine Systolic and Diastolic Blood Pressure, Heart rate) - Columbia-Suicide Severity Rating Scale (C-SSRS);Timepoint(s) of evaluation of this end point: - HAM-D: at W0, W2, W4, W6 and W8 - CGI item 1 at W0, W2, W4, W6 and W8 and item 2 at W2, W4, W6 and W8 - HAD: at W0, W2, W4, W6 and W8 - SDS: at W0, W2, W4, W6 and W8 - Adverse Events: all over the study - Body Weight and BMI: at W4 and W8 - Laboratory tests: at W4 and W8 - 12-lead ECG: at W4 and W8 - Vital signs: at W0, W2, W4, W6 and W8 - C-SSRS: at W0, W2, W4, W6 and W8	—

Measure

Time frame

Secondary end point(s): Depressive symptoms: - HAM-D total score at each visit, - Response to treatment defined by HAM-D total score decrease from baseline = 50% - Clinical Global Impression scale (CGI), item 1 (Severity of depression) and item 2 (global Improvement) scores, response to treatment (CGI item 2 = 1or 2) - Hospital Anxiety and Depression Scale (HAD), Anxiety and Depression sub-scores Social functioning - Sheehan Disability Scale (SDS) scores (Work, social and family life) Safety criteria: - Adverse Events - Body Weight and BMI - Laboratory tests (haematology and biochemistry) - 12-lead ECG - Vital signs (standing and supine Systolic and Diastolic Blood Pressure, Heart rate) - Columbia-Suicide Severity Rating Scale (C-SSRS);Timepoint(s) of evaluation of this end point: - HAM-D: at W0, W2, W4, W6 and W8 - CGI item 1 at W0, W2, W4, W6 and W8 and item 2 at W2, W4, W6 and W8 - HAD: at W0, W2, W4, W6 and W8 - SDS: at W0, W2, W4, W6 and W8 - Adverse Events: all over the study - Body Weight and BMI: at W4 and W8 - Laboratory tests: at W4 and W8 - 12-lead ECG: at W4 and W8 - Vital signs: at W0, W2, W4, W6 and W8 - C-SSRS: at W0, W2, W4, W6 and W8

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Countries

Bulgaria, Czech Republic, Finland, Hungary, Russian Federation, Slovakia, Ukraine

Contacts

Public ContactClinical Studies Department

Institut de Recherches internationales Servier

clinicaltrials@servier.com+33155 72 43 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026