Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder
Information source: Pharmacology Research Institute
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: Escitalopram (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Pharmacology Research Institute Official(s) and/or principal investigator(s):
Jon F. Heiser, MD, Principal Investigator, Affiliation: Pharmacology Research Institute
Nader Oskooilar, MD, Principal Investigator, Affiliation: Pharmacology Research Institute
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.
Clinical Details
Official title: Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Montgomery Asberg Depression Rating Scale (MADRS)
Secondary outcome: Hamilton Depression Rating Scale (HAMD)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Pharmacology Research Institute, Los Alamitos, California 90720, United States
Pharmacology Research Institute, Newport Beach, California 92660, United States
Pharmacology Research Institute, Northridge, California 91324, United States
Pharmacology Research Institute, Riverside, California 92506, United States
Additional Information
Starting date: March 2005
Last updated: April 13, 2006
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