Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

October 13, 2005

Last Updated Date

April 13, 2006

Start Date ^ICMJE

March 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Montgomery Asberg Depression Rating Scale (MADRS)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00239954 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hamilton Depression Rating Scale (HAMD)

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder

Official Title ^ICMJE

Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

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.

Detailed Description

Both active drugs being tested, alone and in combination, in this study are currently available antidepressants. However, the doses used in this study are lower than the standard approved doses.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment

Condition ^ICMJE

Major Depressive Disorder

Intervention ^ICMJE

Drug: Escitalopram

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00239954

Responsible Party

Study ID Numbers ^ICMJE

PRI#591 & #592

Study Sponsor ^ICMJE

Pharmacology Research Institute

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Jon F. Heiser, MD	Pharmacology Research Institute
Principal Investigator:	Nader Oskooilar, MD	Pharmacology Research Institute

Information Provided By

Pharmacology Research Institute

Verification Date

April 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP