search
Back to results

Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
Pharmacology Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • Pharmacology Research Institute
  • Pharmacology Research Institute
  • Pharmacology Research Institute
  • Pharmacology Research Institute

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Hamilton Depression Rating Scale (HAMD)

Full Information

First Posted
October 13, 2005
Last Updated
May 8, 2012
Sponsor
Pharmacology Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00239954
Brief Title
Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder
Official Title
Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmacology Research Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Escitalopram
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale (MADRS)
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HAMD)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon F. Heiser, MD
Organizational Affiliation
Pharmacology Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nader Oskooilar, MD
Organizational Affiliation
Pharmacology Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Pharmacology Research Institute
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Pharmacology Research Institute
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder

We'll reach out to this number within 24 hrs