NCT02805439

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Major Depressive Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2016-06-20
• Last updated: 2020-01-03

Locations

53 sites across 7 countries: Bulgaria, Czechia, Finland, Hungary, Russia, Slovakia, Ukraine