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

NCT01814098 | Completed Phase 4

• 2 other identifiers: CR016381ESCITALDEP4002
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Depressive Disorder, Major

Keywords

Depressive Disorder, Major; Escitalopram; Lexapro

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Remission According to Montgomery-Asbery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale (HAM-A)

  Remission is defined as MADRS total score =\<10 and HAM-A score =\<7. MADRS measures depression severity and detects changes due to antidepressant treatment. It consists of 10 items, each scoring from 0 (not present) to 6 (severe). Total score= 0-60. Higher scores indicate more severe condition. HAM-A is 14-item scale measuring anxiety in individuals. Each question reflects a symptom of anxiety (physical and mental symptoms). The answers range from 0 (complete lack of symptom) to 4 (very severe show of anxiety with that symptom). Total score= 0-56. Higher scores indicate a more severe condition.

  Week 24

Secondary Outcomes (8)

• Percentage of Participants Showing Response

  Week 24

• Change From Baseline in MADRS Total Score at Week 24

  Baseline and Week 24

• Change From Baseline of Single Rating Item in MADRS Total Score at Week 24

  Baseline and Week 24

• Change From Baseline in Hamilton Depression Rating Scale (HAMD)-17 Score at Week 24

  Baseline and Week 24

• Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24

  Baseline and Week 24

Study Arms (1)

Escitalopram

EXPERIMENTAL

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

Drug: Escitalopram

Interventions

Escitalopram DRUG

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

Also known as: Lexapro

Escitalopram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be willing and able to give written informed consent
• Participant currently suffering from Major Depressive Disorder (MDD) with anxious symptoms including participant with first MDD episode, and relapsed participant with new episode
• Participant with minimum score at baseline of 22 on the Montgomery-Asbery Depression Rating Scale (MADRS) and minimum score at baseline of 14 on Hamilton Anxiety Rating (HAM-A) scales
• Female participant must be surgically sterile, or practicing an effective method of birth control before entry and throughout the study

You may not qualify if:

• Participant who has continuously taken psychoactive substances, antidepressants, anxiolytics, monoamine oxidase inhibitors (MAOIs), psychoactive herbal remedies, lithium, electroconvulsive therapy (ECT) carbamazepine in the past 2 weeks before the baseline visit - Participants with MDD, requiring treatment systematically within past 2 months from baseline - Participants who has contraindication to escitalopram - Participant has primary or comorbid diagnoses of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations \[imagining things\], and withdrawal into the self), schizoaffective disorder (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder), bipolar disorder, or dementia (mental decline) - Participant who has a significant risk of suicide on clinical assessment or has made a serious suicide attempt within the past 6-month

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (10)

Unknown Facility

Beijng, China

Location

Unknown Facility

Changsha, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Shenyang, China

Location

Unknown Facility

Shijiazhuang, China

Location

Unknown Facility

Tianjin, China

Location

Unknown Facility

Wenzhou, China

Location

Unknown Facility

Wuhan, China

Location

Related Links

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

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 19, 2013
• Study Start: July 7, 2009
• Primary Completion: May 31, 2011
• Study Completion: November 30, 2011
• Last Updated: October 2, 2017

Record last verified: 2017-09

Locations

CN (10)