Back to resultsA Safety and Efficacy Study of Escitalopram on Acute Treatment of Severe Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Escitalopram, Lexapro
Eligibility Criteria
Inclusion Criteria:
- Participants diagnosed with major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)
- Scores of greater than or equal to 30 on the Montgomery-Asberg Depression Rating Scale (MADRS) Exclusion Criteria:
- Pregnant or lactating female participants
- Participants who are previously or currently diagnosed with the following mental disorders by DSM-IV: organic mental disorder, schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), schizoaffective disorder, delusional disorder, undifferentiated mental disorders and bipolar affective disorder, participants with history of drug abuse, including alcohol and drug abuse in the past 12 months
- Participants who have significant risk of suicide on clinical assessment (has a score of greater than or equal to 5 on item 5 of MADRS) or have made a serious suicide attempt within the past 6 months and have any contraindication to escitalopram
- Participants who have known history of serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease currently taking other psychotropic drugs and anticonvulsant agents or continuously taking benzodiazepines or sleeping pills for over five days in the past one week
- Participants who have history of seizure (sudden, uncontrolled muscle spasms and loss of consciousness resulting from abnormal brain function) disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative diseases, parkinson disease and any movement disorders) and have multiple drug adverse reactions
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Escitalopram
Arm Description
Escitalopram tablets will be administered orally in the dose range of 10 to 20 milligram per day (mg/day) for 8 weeks. Dose can be adjusted as per Investigator's discretion depending on participant's response.
Outcomes
Primary Outcome Measures
Percentage of Participants With Remission Based on Montgomery-Asberg Depression Rating Scale (MADRS)
Remission is defined as percentage of participants with MADRS total score less than or equal to10 at the endpoint (8 weeks). 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 score represents a more severe condition.
Secondary Outcome Measures
Percentage of Participants With Clinical Response Based on Montgomery-Asberg Depression Rating Scale (MADRS)
Clinical response is defined as greater than or equal to 50 percent change from Baseline in MARDS total scores at end point (8 weeks). 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 score represents a more severe condition.
Percentage of Participants With Clinical Onset Based on Montgomery-Asberg Depression Rating Scale (MADRS)
Clinical onset is defined as the reduction rate of MADRS total score greater than or equal to 20 percent. 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 score represents a more severe condition.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 1, 2, 4 and 8
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 score represents a more severe condition.
Change From Baseline in Hamilton Depression Rating Scale (HAM-D-17) Score at Week 1, 2, 4 and 8
The Hamilton Depression Rating (HAM-D-17) Scale is a 17-item scale used to assess the severity of depression in participants diagnosed with an affective disorder. Items are scored from 0 to 4, the higher the score, the more severe the depression. Questions are related to symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss.
Change From Baseline in Hamilton Anxiety Scale (HAMA) Score at Week 1, 2, 4 and 8
The Hamilton Anxiety Rating (HAMA) Scale is a 14-item scale developed to measure the severity of symptoms such as anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, restlessness and other physical symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe).
Change From Baseline in Brain-Derived Neurotrophic Factor (BDNF) at Week 8
Serum BDNF levels normally decrease in participants suffering from Major Depressive Disorder (MDD) and the decrease is more prominent in participants with long disease course but this can also increase in response to antidepressants. The enzyme-linked immunosorbent assay (ELISA) method will be used to evaluate the serum BDNF level before and after using escitalopram, and use it as a biological marker for predicting the early efficacy of taking antidepressants.
Change From Baseline in Short Form-12 (SF-12) Score at Week 8
The SF-12 health survey is the 12-item sub form of Short form (SF-36), investigating 8 health dimensions: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. This 12-item scale measures health conditions and describes the level of general physical health state and mental health problems.
Change from Baseline in Plasma Drug Concentration at Week 1 and 8
Plasma concentration of study drug will be assessed in blood samples.
Number of Participants with Structural and Functional Changes in Magnetic Resonance Imaging (MRI) at Week 8
Major depressive disorder participants have distinctive prefrontal cortex, hippocampal atrophy (wasting away, or decrease in size, of a body organ) and amygdala function abnormalities. Structural and functional MRI (body pictures created using magnetic waves to look at soft tissues of the body) can help to evaluate the efficacy of escitalopram on neural plasticity.
Full Information
NCT ID
NCT01814085
First Posted
March 14, 2013
Last Updated
January 2, 2014
Sponsor
Xian-Janssen Pharmaceutical Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01814085
Brief Title
A Safety and Efficacy Study of Escitalopram on Acute Treatment of Severe Depression
Official Title
A Single-arm, Open-label, Multi-center Study to Investigate Efficacy and Safety of Lexapro on Acute Treatment of Severe Depression
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xian-Janssen Pharmaceutical Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of escitalopram treatment in participants with severe major depressive disorder (MDD [marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation]).
Detailed Description
This is a single-arm (clinical study in only one group of participants), open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), and prospective (study following participants forward in time) study. The study consists of 2 parts: Screening (that is, 5 days before study commences on Day 1) and Treatment (that is, Week 1-8). All the eligible participants will be receiving flexible doses of escitalopram orally in the dose range of 10 to 20 milligram per day (mg/day) for 8 weeks. Efficacy will primarily be evaluated by remission rate at the end of the study. Participants' safety will be monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, 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
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
Escitalopram tablets will be administered orally in the dose range of 10 to 20 milligram per day (mg/day) for 8 weeks. Dose can be adjusted as per Investigator's discretion depending on participant's response.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
Escitalopram tablets will be administered orally in the dose range of 10 to 20 milligram per day (mg/day) for 8 weeks. Dose can be adjusted as per Investigator's discretion depending on participant's response.
Primary Outcome Measure Information:
Title
Percentage of Participants With Remission Based on Montgomery-Asberg Depression Rating Scale (MADRS)
Description
Remission is defined as percentage of participants with MADRS total score less than or equal to10 at the endpoint (8 weeks). 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 score represents a more severe condition.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinical Response Based on Montgomery-Asberg Depression Rating Scale (MADRS)
Description
Clinical response is defined as greater than or equal to 50 percent change from Baseline in MARDS total scores at end point (8 weeks). 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 score represents a more severe condition.
Time Frame
Baseline and Week 8
Title
Percentage of Participants With Clinical Onset Based on Montgomery-Asberg Depression Rating Scale (MADRS)
Description
Clinical onset is defined as the reduction rate of MADRS total score greater than or equal to 20 percent. 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 score represents a more severe condition.
Time Frame
Baseline and Week 8
Title
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 1, 2, 4 and 8
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 score represents a more severe condition.
Time Frame
Baseline, Week 1, 2, 4 and 8
Title
Change From Baseline in Hamilton Depression Rating Scale (HAM-D-17) Score at Week 1, 2, 4 and 8
Description
The Hamilton Depression Rating (HAM-D-17) Scale is a 17-item scale used to assess the severity of depression in participants diagnosed with an affective disorder. Items are scored from 0 to 4, the higher the score, the more severe the depression. Questions are related to symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss.
Time Frame
Baseline, Week 1, 2, 4 and 8
Title
Change From Baseline in Hamilton Anxiety Scale (HAMA) Score at Week 1, 2, 4 and 8
Description
The Hamilton Anxiety Rating (HAMA) Scale is a 14-item scale developed to measure the severity of symptoms such as anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, restlessness and other physical symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe).
Time Frame
Baseline, Week 1, 2, 4 and 8
Title
Change From Baseline in Brain-Derived Neurotrophic Factor (BDNF) at Week 8
Description
Serum BDNF levels normally decrease in participants suffering from Major Depressive Disorder (MDD) and the decrease is more prominent in participants with long disease course but this can also increase in response to antidepressants. The enzyme-linked immunosorbent assay (ELISA) method will be used to evaluate the serum BDNF level before and after using escitalopram, and use it as a biological marker for predicting the early efficacy of taking antidepressants.
Time Frame
Baseline and Week 8
Title
Change From Baseline in Short Form-12 (SF-12) Score at Week 8
Description
The SF-12 health survey is the 12-item sub form of Short form (SF-36), investigating 8 health dimensions: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. This 12-item scale measures health conditions and describes the level of general physical health state and mental health problems.
Time Frame
Baseline and Week 8
Title
Change from Baseline in Plasma Drug Concentration at Week 1 and 8
Description
Plasma concentration of study drug will be assessed in blood samples.
Time Frame
Baseline, Week 1 and 8
Title
Number of Participants with Structural and Functional Changes in Magnetic Resonance Imaging (MRI) at Week 8
Description
Major depressive disorder participants have distinctive prefrontal cortex, hippocampal atrophy (wasting away, or decrease in size, of a body organ) and amygdala function abnormalities. Structural and functional MRI (body pictures created using magnetic waves to look at soft tissues of the body) can help to evaluate the efficacy of escitalopram on neural plasticity.
Time Frame
Baseline and Week 8
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:
Participants diagnosed with major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)
Scores of greater than or equal to 30 on the Montgomery-Asberg Depression Rating Scale (MADRS) Exclusion Criteria:
Pregnant or lactating female participants
Participants who are previously or currently diagnosed with the following mental disorders by DSM-IV: organic mental disorder, schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), schizoaffective disorder, delusional disorder, undifferentiated mental disorders and bipolar affective disorder, participants with history of drug abuse, including alcohol and drug abuse in the past 12 months
Participants who have significant risk of suicide on clinical assessment (has a score of greater than or equal to 5 on item 5 of MADRS) or have made a serious suicide attempt within the past 6 months and have any contraindication to escitalopram
Participants who have known history of serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease currently taking other psychotropic drugs and anticonvulsant agents or continuously taking benzodiazepines or sleeping pills for over five days in the past one week
Participants who have history of seizure (sudden, uncontrolled muscle spasms and loss of consciousness resulting from abnormal brain function) disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative diseases, parkinson disease and any movement disorders) and have multiple drug adverse reactions
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
Beijing
Country
China
City
Huzhou
Country
China
City
Nanjing
Country
China
City
Qingdao
Country
China
City
Shanghai
Country
China
City
Wuhan
Country
China
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=2340&filename=CR016300_CSR.pdf
Description
A Single-arm, Open-label, Multi-center Study to Investigate Efficacy and Safety of Lexapro on Acute Treatment of Severe Depression
Learn more about this trial
A Safety and Efficacy Study of Escitalopram on Acute Treatment of Severe Depression
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