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Trial record 76 of 531 for:    ESCITALOPRAM AND Disorders

A Safety and Efficacy Study of Escitalopram on Acute Treatment of Severe Depression

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ClinicalTrials.gov Identifier: NCT01814085
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : January 3, 2014
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.

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]).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Escitalopram Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Open-label, Multi-center Study to Investigate Efficacy and Safety of Lexapro on Acute Treatment of Severe Depression
Study Start Date : February 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Escitalopram
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.
Drug: Escitalopram
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.
Other Name: Lexapro




Primary Outcome Measures :
  1. Percentage of Participants With Remission Based on Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Week 8 ]
    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 :
  1. Percentage of Participants With Clinical Response Based on Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline and Week 8 ]
    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.

  2. Percentage of Participants With Clinical Onset Based on Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline and Week 8 ]
    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.

  3. Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 1, 2, 4 and 8 [ Time Frame: Baseline, 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.

  4. Change From Baseline in Hamilton Depression Rating Scale (HAM-D-17) Score at Week 1, 2, 4 and 8 [ Time Frame: Baseline, 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.

  5. Change From Baseline in Hamilton Anxiety Scale (HAMA) Score at Week 1, 2, 4 and 8 [ Time Frame: Baseline, 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).

  6. Change From Baseline in Brain-Derived Neurotrophic Factor (BDNF) at Week 8 [ Time Frame: Baseline and 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.

  7. Change From Baseline in Short Form-12 (SF-12) Score at Week 8 [ Time Frame: Baseline and 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.

  8. Change from Baseline in Plasma Drug Concentration at Week 1 and 8 [ Time Frame: Baseline, Week 1 and 8 ]
    Plasma concentration of study drug will be assessed in blood samples.

  9. Number of Participants with Structural and Functional Changes in Magnetic Resonance Imaging (MRI) at Week 8 [ Time Frame: Baseline and 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814085


Locations
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China
Beijing, China
Huzhou, China
Nanjing, China
Qingdao, China
Shanghai, China
Wuhan, China
Sponsors and Collaborators
Xian-Janssen Pharmaceutical Ltd.
Investigators
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Study Director: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial Xian-Janssen Pharmaceutical Ltd.

Additional Information:
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Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT01814085     History of Changes
Other Study ID Numbers: CR016300
ESCITALDEP4001
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: January 2014

Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
Major Depressive Disorder
Escitalopram
Lexapro

Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
Depression
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents