- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01594866
Lexapro®'s Efficacy After Dose Escalation in Remission Study (LEADERS)
September 5, 2018 updated by: Yong Min Ahn, Seoul National University Hospital
A Double-blinded 6-week Prospective Study to Evaluate the Remission Rate According to Dose of Escitalopram (Lexapro®) in Patients With Major Depressive Disorder: a Preliminary Study
The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and 30 mg in patients with major depressive disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this study, the investigators are going to examine the efficacy of escitalopram after dose escalation and evaluate remission rate.
This study design is the double-blinded 6-week prospective study.
It would be useful for clinicians because there were few study of high-dose antidepressant treatment in lack of remission in major depressive disorder patients.
To control of bias, the investigators included patients with lack of remission after 4-week escitalopram treatment.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 18 ~ 65
- Patient with major depressive disorder according to DSM-IV criteria
- Patient have signed on the informed consent, and well understood the objective and procedure of this study.
- MADRS total score ≥ 18
- Competent patient who is manage to answer the questionnaires.
- In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.
Exclusion Criteria:
- In previous depressive episodes, no efficacy although more than one antidepressant treatment
- Allergy or hypersensitivity to escitalopram
- Diagnosed to schizophrenia or bipolar disorder or schizoaffective disorder (DSM-IV)
- MADRS 10 score ≥ 5, or patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion
- Pregnant or breast-feeding female patient
- Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion
- Significant severe medical condition
- Patients who take antipsychotics or mood stabilizer or other psychiatric drugs excluding benzodiazepines or beta blockers or hypnotics
- History of participating to other investigational drug trial within 1month prior to screening
- Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Escitalopram, 20mg, placebo
escitalopram 20mg + placebo (same taste, appearance, texture of escitalopram 10mg)
|
escitalopram 20mg and 30mg p.o. daily, 6 weeks
Other Names:
escitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups
Other Names:
|
Experimental: Escitalopram 20mg, escitalopram 10mg
Escitalopram 20mg + Escitalopram 10mg
|
escitalopram 20mg and 30mg p.o. daily, 6 weeks
Other Names:
escitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hamilton Depression Rating Scale-17 items (HAM-D)
Time Frame: 6 weeks
|
6 weeks
|
Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: 6 weeks
|
6 weeks
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Clinical Global Impression-severity (CGI-S)
Time Frame: 6 weeks
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6 weeks
|
Clinical Global Impression-Improvement (CGI-I)
Time Frame: 6 weeks
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6 weeks
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Beck's Depression Inventory(BDI)
Time Frame: 6 weeks
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6 weeks
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WHO Quality Of Life scale Abbreviated Version(WHOQOL-BREF)
Time Frame: 6 weeks
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6 weeks
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Clinically Useful Depression Outcome Scale (CUDOS)
Time Frame: 6 weeks
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6 weeks
|
Short From-36 Health survey (SF-36 Health survey)
Time Frame: 6 weeks
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6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
May 7, 2012
First Submitted That Met QC Criteria
May 8, 2012
First Posted (Estimate)
May 9, 2012
Study Record Updates
Last Update Posted (Actual)
September 7, 2018
Last Update Submitted That Met QC Criteria
September 5, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Citalopram
- Dexetimide
Other Study ID Numbers
- AYM-LEADERS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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