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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

NCT02805439 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-01-03

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

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.

Sponsors & Collaborators

  • ADIR Association

    collaborator OTHER

  • Institut de Recherches Internationales Servier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Bulgaria
  • Czechia
  • Finland
  • Hungary
  • Russia
  • Slovakia
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02805439 on ClinicalTrials.gov