Lexapro®'s Efficacy After Dose Escalation in Remission Study

Phase 4

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: escitalopram

• Registration Number: NCT01594866
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-09
• Primary Completion: 2016-06
• Study Completion: 2016-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Escitalopram, 20mg, placebo	escitalopram	escitalopram 20mg + placebo (same taste, appearance, texture of escitalopram 10mg)
Escitalopram 20mg, escitalopram 10mg	escitalopram	Escitalopram 20mg + Escitalopram 10mg

Primary Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale (MADRS)	6 weeks

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale-17 items (HAM-D)	6 weeks
Hamilton Anxiety Rating Scale (HAM-A)	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
Clinical Global Impression-severity (CGI-S)	6 weeks
Clinical Global Impression-Improvement (CGI-I)	6 weeks

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of