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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
escitalopram
escitalopram
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, remission, escitalopram

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Escitalopram, 20mg, placebo

Escitalopram 20mg, escitalopram 10mg

Arm Description

escitalopram 20mg + placebo (same taste, appearance, texture of escitalopram 10mg)

Escitalopram 20mg + Escitalopram 10mg

Outcomes

Primary Outcome Measures

Montgomery-Åsberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

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

Full Information

First Posted
May 7, 2012
Last Updated
September 5, 2018
Sponsor
Seoul National University Hospital
Collaborators
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01594866
Brief Title
Lexapro®'s Efficacy After Dose Escalation in Remission Study
Acronym
LEADERS
Official Title
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
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, remission, escitalopram

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram, 20mg, placebo
Arm Type
Placebo Comparator
Arm Description
escitalopram 20mg + placebo (same taste, appearance, texture of escitalopram 10mg)
Arm Title
Escitalopram 20mg, escitalopram 10mg
Arm Type
Experimental
Arm Description
Escitalopram 20mg + Escitalopram 10mg
Intervention Type
Drug
Intervention Name(s)
escitalopram
Other Intervention Name(s)
Lexapro®
Intervention Description
escitalopram 20mg and 30mg p.o. daily, 6 weeks
Intervention Type
Drug
Intervention Name(s)
escitalopram
Other Intervention Name(s)
Lexapro®
Intervention Description
escitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups
Primary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale-17 items (HAM-D)
Time Frame
6 weeks
Title
Hamilton Anxiety Rating Scale (HAM-A)
Time Frame
6 weeks
Title
Clinical Global Impression-severity (CGI-S)
Time Frame
6 weeks
Title
Clinical Global Impression-Improvement (CGI-I)
Time Frame
6 weeks
Title
Beck's Depression Inventory(BDI)
Time Frame
6 weeks
Title
WHO Quality Of Life scale Abbreviated Version(WHOQOL-BREF)
Time Frame
6 weeks
Title
Clinically Useful Depression Outcome Scale (CUDOS)
Time Frame
6 weeks
Title
Short From-36 Health survey (SF-36 Health survey)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Min Ahn, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Lexapro®'s Efficacy After Dose Escalation in Remission Study

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