Lexapro®'s Efficacy After Dose Escalation in Remission Study

Study Overview
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Brief Summary
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The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and 30 mg in patients with major depressive disorder.

Detailed Description
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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.

Official Title
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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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: escitalopram
* Drug: escitalopram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Escitalopram, 20mg, placebo<br>escitalopram 20mg + placebo (same taste, appearance, texture of escitalopram 10mg) | Drug: escitalopram<br>* escitalopram 20mg and 30mg p.o. daily, 6 weeks<br>* Other names: Lexapro®;Drug: escitalopram<br>* escitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups<br>* Other names: Lexapro®;|
| Experimental: Escitalopram 20mg, escitalopram 10mg<br>Escitalopram 20mg + Escitalopram 10mg | Drug: escitalopram<br>* escitalopram 20mg and 30mg p.o. daily, 6 weeks<br>* Other names: Lexapro®;Drug: escitalopram<br>* escitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups<br>* Other names: Lexapro®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Åsberg Depression Rating Scale (MADRS) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale-17 items (HAM-D) |  | 6 weeks | 
| Hamilton Anxiety Rating Scale (HAM-A) |  | 6 weeks | 
| Clinical Global Impression-severity (CGI-S) |  | 6 weeks | 
| Clinical Global Impression-Improvement (CGI-I) |  | 6 weeks | 
| Beck's Depression Inventory(BDI) |  | 6 weeks | 
| WHO Quality Of Life scale Abbreviated Version(WHOQOL-BREF) |  | 6 weeks | 
| Clinically Useful Depression Outcome Scale (CUDOS) |  | 6 weeks | 
| Short From-36 Health survey (SF-36 Health survey) |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depressive disorder, remission, escitalopram