Lexapro®'s Efficacy After Dose Escalation in Remission Study (LEADERS)

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: Major Depressive Disorder
• Intervention / Treatment: Drug: escitalopram; Drug: escitalopram

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

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: H. Lundbeck A/S

Study record dates

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

• Keywords: Major depressive disorder, remission, escitalopram
• 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