Lexapro®’s Efficacy After Dose Escalation in Remission Study

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2016

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.

Interventions

  • Drug: escitalopram
    • escitalopram 20mg and 30mg p.o. daily, 6 weeks
  • Drug: escitalopram
    • escitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups

Arms, Groups and Cohorts

  • Placebo Comparator: Escitalopram, 20mg, placebo
    • escitalopram 20mg + placebo (same taste, appearance, texture of escitalopram 10mg)
  • Experimental: Escitalopram 20mg, escitalopram 10mg
    • Escitalopram 20mg + Escitalopram 10mg

Clinical Trial Outcome Measures

Primary Measures

  • Montgomery-Åsberg Depression Rating Scale (MADRS)
    • Time Frame: 6 weeks

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • H. Lundbeck A/S
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yong Min Ahn, professor – Seoul National University Hospital
  • Overall Official(s)
    • Yong Min Ahn, MD, PhD, Principal Investigator, Seoul National University Hospital

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