Major Depressive Disorder
Conditions
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.
Interventions
DRUGS47445 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.
DRUGS47445 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.
DRUGPlacebo
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.
Sponsors
ADIR Association
Institut de Recherches Internationales Servier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAM-D) total score expressed as change from baseline value | 8 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Sheehan Disability Scale (SDS) scores (Work, social and family life) | at week 0, week 2, week 4, week 6 and week 8 | Social functioning |
| Adverse Events | through study completion (an average of 12 weeks) | 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 |
| Laboratory tests (haematology and biochemistry) | at week 4 and week 8 | Safety criterion |
| 12-lead ECG | 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 |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | at week 0, week 2, week 4, week 6 and week 8 | Safety criterion |
| Body Weight | at week 4 and week 8 | Safety criterion |
Countries
Bulgaria, Czechia, Finland, Hungary, Russia, Slovakia, Ukraine
Outcome results
None listed