NCT01814098

An Efficacy and Safety Study of Escitalopram Long-Term Treatment in Major Depressive Disorder With Associated Anxiety Symptoms

Escitalopram in the Long-term Treatment of Major Depressive Disorder With Associated Anxiety Symptom

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Xian-Janssen Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of long term escitalopram treatment in participants with Major Depressive Disorder (MDD) with associated anxiety symptoms.

Detailed description

This is an open-label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time), post-marketing, multi-center (when more than one hospital or medical school team work on a medical research study) study to evaluate the efficacy and safety of escitalopram in participants with MDD with associated anxiety symptoms. The duration of the study will be 24 weeks at a starting dose of escitalopram 10 milligram per day (mg/day). The dose will be flexibly adjusted (maximum 20 mg/day) after 2 weeks of treatment depending on Investigator's discretion. The study will consist of 9 visits: Baseline, Week 1, 2, 4, 8, 12, 16, 20 and 24. Assessments of efficacy and safety will be performed at each visit. The primary efficacy evaluation will be done by Montgomery-Asbery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale(HAM-A). Participant's safety will also be monitored throughout the study.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Escitalopram	Escitalopram tablets will be administered orally at 10 milligram per day (mg/day). The dose may be increased to maximum of 20 mg/day depending on Investigators discretion for 24 weeks

Timeline

• Start date: 2009-07-07
• Primary completion: 2011-05-31
• Completion: 2011-11-30
• First posted: 2013-03-19
• Last updated: 2017-10-02

Locations

10 sites across 1 country: China