NCT00239954

Brief Summary

The purpose of this study is to evaluate the effectiveness, safety and tolerability of an escitalopram combination treatment compared to single treatments, and to placebo in patients with major depressive disorder.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

4 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
Last Updated

May 9, 2012

Status Verified

May 1, 2012

First QC Date

October 13, 2005

Last Update Submit

May 8, 2012

Conditions

Major Depressive Disorder

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
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 (4)

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Pharmacology Research Institute

Northridge, California, 91324, United States

Location

Pharmacology Research Institute

Riverside, California, 92506, United States

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

  • Jon F. Heiser, MD

    Pharmacology Research Institute

    PRINCIPAL INVESTIGATOR

  • Nader Oskooilar, MD

    Pharmacology Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

March 1, 2005

Last Updated

May 9, 2012

Record last verified: 2012-05

Locations

US(4)