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Trial record 1 of 593 for:    ESCITALOPRAM AND Celexa
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An Efficacy and Safety Study of Escitalopram Long-Term Treatment in Major Depressive Disorder With Associated Anxiety Symptoms (Lexapro)

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ClinicalTrials.gov Identifier: NCT01814098
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.

Tracking Information
First Submitted Date  ICMJE March 14, 2013
First Posted Date  ICMJE March 19, 2013
Last Update Posted Date October 2, 2017
Actual Study Start Date  ICMJE July 7, 2009
Actual Primary Completion Date May 31, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2013)
Percentage of Participants With Remission According to Montgomery-Asbery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale (HAM-A) [ Time Frame: Week 24 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01814098 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2013)
  • Percentage of Participants Showing Response [ Time Frame: Week 24 ]
    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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of Escitalopram Long-Term Treatment in Major Depressive Disorder With Associated Anxiety Symptoms
Official Title  ICMJE Escitalopram in the Long-term Treatment of Major Depressive Disorder With Associated Anxiety Symptom
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE 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 Name: Lexapro
Study Arms  ICMJE 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
Intervention: Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2013)
318
Original Actual Enrollment  ICMJE
 (submitted: March 14, 2013)
304
Actual Study Completion Date  ICMJE November 30, 2011
Actual Primary Completion Date May 31, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01814098
Other Study ID Numbers  ICMJE CR016381
ESCITALDEP4002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xian-Janssen Pharmaceutical Ltd.
Study Sponsor  ICMJE Xian-Janssen Pharmaceutical Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial Xian-Janssen Pharmaceutical Ltd.
PRS Account Xian-Janssen Pharmaceutical Ltd.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP