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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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ClinicalTrials.gov Identifier: NCT02805439
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : January 3, 2020
Sponsor:
Collaborator:
ADIR Association
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: S47445 15mg Drug: S47445 50mg Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arms and Interventions
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Arm Intervention/treatment
Experimental: S47445 15mg Drug: S47445 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.
Experimental: S47445 50mg Drug: S47445 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.
Placebo Comparator: Placebo Drug: Placebo
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.


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton Depression Rating Scale (HAM-D) total score expressed as change from baseline value [ Time Frame: 8 weeks of treatment ]

Secondary Outcome Measures :
  1. HAM-D total score [ Time Frame: at week 0, week 2, week 4, week 6 and week 8 ]
    Depressive symptoms

  2. 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 ]
    Depressive symptoms

  3. 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 ]
    Depressive symptoms

  4. 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 ]
    Depressive symptoms

  5. Sheehan Disability Scale (SDS) scores (Work, social and family life) [ Time Frame: at week 0, week 2, week 4, week 6 and week 8 ]
    Social functioning

  6. Adverse Events [ Time Frame: through study completion (an average of 12 weeks) ]
    Safety criterion

  7. Body Weight [ Time Frame: at week 4 and week 8 ]
    Safety criterion

  8. BMI [ Time Frame: at week 4 and week 8 ]
    Safety criterion

  9. Laboratory tests (haematology and biochemistry) [ Time Frame: at week 4 and week 8 ]
    Safety criterion

  10. 12-lead ECG [ Time Frame: at week 4 and week 8 ]
    Safety criterion

  11. 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 ]
    Safety criterion

  12. Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: at week 0, week 2, week 4, week 6 and week 8 ]
    Safety criterion


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805439


Locations
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Sponsors and Collaborators
Institut de Recherches Internationales Servier
ADIR Association
More Information
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Additional Information:

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Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT02805439    
Other Study ID Numbers: CL2-47445-014
2015-003867-13 ( EudraCT Number )
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
URL: https://clinicaltrials.servier.com/
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms