Lexapro®'s Efficacy After Dose Escalation in Remission Study | NCT01594866

Studies
Lexapro®'s Efficacy After Dose Escalation in Remission Study

NCT01594866

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Sep 7, 2018Actual

Enrollment

60Estimated

Phase

Phase 4

Conditions

Major Depressive Disorder

Interventions

escitalopram
escitalopram

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jun 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

May 7, 2012

First Submission Date that Met QC Criteria

May 8, 2012

First Posted Date

May 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2018

Last Update Posted Date

Sep 7, 2018Actual

Name	Class
H. Lundbeck A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Escitalopram, 20mg, placebo	Placebo Comparator	escitalopram 20mg + placebo (same taste, appearance, texture of escitalopram 10mg)	Drug: escitalopram
Escitalopram 20mg, escitalopram 10mg	Experimental	Escitalopram 20mg + Escitalopram 10mg	Drug: escitalopram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
escitalopram	Drug	escitalopram 20mg and 30mg p.o. daily, 6 weeks	Escitalopram 20mg, escitalopram 10mg Escitalopram, 20mg, placebo

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

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)

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572