Depressive Disorder, Major Clinical Trial
— LexaproOfficial title:
Escitalopram in the Long-term Treatment of Major Depressive Disorder With Associated Anxiety Symptom
Verified date | September 2017 |
Source | Xian-Janssen Pharmaceutical Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 318 |
Est. completion date | November 30, 2011 |
Est. primary completion date | May 31, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Xian-Janssen Pharmaceutical Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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