Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00239954
• Other study ID #: PRI#591 & #592
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 13, 2005
• Last updated: May 8, 2012
• Start date: March 2005

Study information

• Verified date: May 2012
• Source: Pharmacology Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Escitalopram

Locations

Country	Name	City	State
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Pharmacology Research Institute	Newport Beach	California
United States	Pharmacology Research Institute	Northridge	California
United States	Pharmacology Research Institute	Riverside	California

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacology Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale (MADRS)
Secondary	Hamilton Depression Rating Scale (HAMD)