Clareo Health | 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 in Depressed Patients Not Fully Recovered From Depressive Symptoms With a Current Antidepressant Treatment
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Keep this study
Lead
Institut de Recherches Internationales Servier
With
ADIR Association
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
