Back to resultsAn Efficacy and Safety Study of Escitalopram Long-Term Treatment in Major Depressive Disorder With Associated Anxiety Symptoms (Lexapro)
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depressive Disorder, Major, Escitalopram, Lexapro
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Escitalopram
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01814098
First Posted
March 14, 2013
Last Updated
September 28, 2017
Sponsor
Xian-Janssen Pharmaceutical Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01814098
Brief Title
An Efficacy and Safety Study of Escitalopram Long-Term Treatment in Major Depressive Disorder With Associated Anxiety Symptoms
Acronym
Lexapro
Official Title
Escitalopram in the Long-term Treatment of Major Depressive Disorder With Associated Anxiety Symptom
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 7, 2009 (Actual)
Primary Completion Date
May 31, 2011 (Actual)
Study Completion Date
November 30, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xian-Janssen Pharmaceutical Ltd.
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Depressive Disorder, Major, Escitalopram, Lexapro
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
318 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Participants With Remission According to Montgomery-Asbery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale (HAM-A)
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Showing Response
Description
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.
Time Frame
Week 24
Title
Change From Baseline in MADRS Total Score at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Change From Baseline of Single Rating Item in MADRS Total Score at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Hamilton Depression Rating Scale (HAMD)-17 Score at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Change From Baseline of Single Rating Item in HAM-A at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Clinical Global Impression Score (CGI-S) at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Short Form-12 (SF-12) Score at Week 24
Description
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.
Time Frame
Baseline and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
Organizational Affiliation
Xian-Janssen Pharmaceutical Ltd.
Official's Role
Study Director
Facility Information:
City
Beijng
Country
China
City
Changsha
Country
China
City
Hangzhou
Country
China
City
Nanjing
Country
China
City
Shanghai
Country
China
City
Shenyang
Country
China
City
Shijiazhuang
Country
China
City
Tianjin
Country
China
City
Wenzhou
Country
China
City
Wuhan
Country
China
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=2348&filename=CR016381_CSR.pdf
Description
Escitalopram in the Long-term Treatment of Major Depressive Disorder With Associated Anxiety Symptom
Learn more about this trial
An Efficacy and Safety Study of Escitalopram Long-Term Treatment in Major Depressive Disorder With Associated Anxiety Symptoms
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