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

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Escitalopram

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.

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijng, China
  • Changsha, China
  • Hangzhou, China
  • Nanjing, China
  • Shanghai, China
  • Shenyang, China
  • Shijiazhuang, China
  • Tianjin, China
  • Wenzhou, China
  • Wuhan, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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; Other Names: Lexapro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Showing Response	Response is defined as having more than or equal to 50 percent decrease from baseline of MADRS total score. The MADRS is a scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.	Week 24
Change From Baseline in MADRS Total Score at Week 24	The MADRS is a scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.	Baseline and Week 24
Change From Baseline of Single Rating Item in MADRS Total Score at Week 24	The MADRS is a scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.	Baseline and Week 24
Change From Baseline in Hamilton Depression Rating Scale (HAMD)-17 Score at Week 24	The depressive symptoms will be assessed using the 17-item HAMD scale, which provides a total score (0-52) (sum of the scores of all 17 items ). For total score of each item, higher score indicates severity of depressive symptom.	Baseline and Week 24
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24	The HAM-A is a 14-item scale designed to measure anxiety in individuals,which provide a total score of 0-56. Higher scores indicate a more severe condition. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom.	Baseline and Week 24
Change From Baseline of Single Rating Item in HAM-A at Week 24	The HAM-A is a 14-item scale designed to measure anxiety in individuals,which provide a total score of 0-56. Higher scores indicate a more severe condition. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom.	Baseline and Week 24
Change From Baseline in Clinical Global Impression Score (CGI-S) at Week 24	The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.	Baseline and Week 24
Change From Baseline in Short Form-12 (SF-12) Score at Week 24	The SF-12 consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health Each item is scored into on a 0-100 range. All items are scored so that a high score defines a more favorable health state.	Baseline and Week 24

Collaborators and Investigators

• Sponsor: Xian-Janssen Pharmaceutical Ltd.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 7, 2009
• Primary Completion (ACTUAL): May 31, 2011
• Study Completion (ACTUAL): November 30, 2011

Study Registration Dates

• First Submitted: March 14, 2013
• First Submitted That Met QC Criteria: March 14, 2013
• First Posted (ESTIMATE): March 19, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 2, 2017
• Last Update Submitted That Met QC Criteria: September 28, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Depressive Disorder, Major; Escitalopram; Lexapro
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: CR016381; ESCITALDEP4002

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No