NCT00384436

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients

Trial Health

80
On Track

Trial Health Score

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

Enrollment
580

participants targeted

Target at 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

October 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

January 7, 2008

Status Verified

January 1, 2008

Enrollment Period

1 year

First QC Date

October 3, 2006

Last Update Submit

January 3, 2008

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Time to premature discontinuation

Secondary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale (MADRS)

Interventions

escitalopramDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must meet DSM-IV criteria for Major Depressive Disorder.
  • Patients must have severe depression.
  • MADRS greater than or equal to 30

You may not qualify if:

  • Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
  • Patients who are considered a suicide risk.
  • Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia.
  • Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder.
  • Patients with history of any psychotic disorder or any psychotic feature.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For information regarding investigative sites, contact Forest Professional Affairs

St Louis, Missouri, 63045, United States

Location

Related Publications (2)

  • Bose A, Tsai J, Li D. Early non-response in patients with severe depression: escitalopram up-titration versus switch to duloxetine. Clin Drug Investig. 2012 Jun 1;32(6):373-85. doi: 10.2165/11631890-000000000-00000.

    PMID: 22559255DERIVED

  • Signorovitch J, Ramakrishnan K, Ben-Hamadi R, Yu AP, Wu EQ, Dworak H, Erder MH. Remission of major depressive disorder without adverse events: a comparison of escitalopram versus serotonin norepinephrine reuptake inhibitors. Curr Med Res Opin. 2011 Jun;27(6):1089-96. doi: 10.1185/03007995.2011.567255. Epub 2011 Mar 28.

    PMID: 21438794DERIVED

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 Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2006

First Posted

October 6, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2007

Last Updated

January 7, 2008

Record last verified: 2008-01

Locations

US(1)