NCT00108979

Brief Summary

Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the efficacy, safety, and pharmacoeconomics of escitalopram and an active comparator 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
240

participants targeted

Target at P25-P50 for phase_3 major-depressive-disorder

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

9 active sites

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

March 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

March 5, 2012

Status Verified

March 1, 2012

Enrollment Period

1.3 years

First QC Date

April 21, 2005

Last Update Submit

March 1, 2012

Conditions

Major Depressive Disorder

Keywords

DepressionMajor Depressive DisorderEscitalopram

Outcome Measures

Primary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale (MADRS)

Secondary Outcomes (1)

  • Hamilton Depression Rating Scale (HAMD)

Interventions

EscitalopramDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
  • The patient's current depressive episode must be at least 12 weeks in duration.

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 currently meet DSM-IV criteria for: a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder.
  • Patients who are considered a suicide risk.
  • Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Southwest Health, Ltd.

Phoenix, Arizona, 85016, United States

Location

Summit Research Network

Okemos, Michigan, 48864, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

CNS Research Institute

Philadelphia, Pennsylvania, 19149, United States

Location

Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States

Location

Radiant Research

Salt Lake City, Utah, 84107, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

Summit Research Network

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • 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, MajorDepression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 21, 2005

First Posted

April 22, 2005

Study Start

March 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

March 5, 2012

Record last verified: 2012-03

Locations

US(9)