NCT01594866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 major-depressive-disorder

Timeline
Completed

Started May 2012

Longer than P75 for phase_4 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

4.1 years

First QC Date

May 7, 2012

Last Update Submit

September 5, 2018

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder, remission, escitalopram

Outcome Measures

Primary Outcomes (1)

  • Montgomery-Åsberg Depression Rating Scale (MADRS)

    6 weeks

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

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

escitalopramDRUG

escitalopram 20mg and 30mg p.o. daily, 6 weeks

Also known as: Lexapro®
Escitalopram 20mg, escitalopram 10mgEscitalopram, 20mg, placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Yong Min Ahn, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 7, 2012

First Posted

May 9, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations

KR(1)