Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2006 by Pharmacology Research Institute. Recruitment status was Active, not recruiting

First Received on October 13, 2005. Last Updated on April 13, 2006 History of Changes

Sponsor:	Pharmacology Research Institute
Information provided by:	Pharmacology Research Institute
ClinicalTrials.gov Identifier:	NCT00239954

Purpose

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.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Escitalopram	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Pharmacology Research Institute:

Primary Outcome Measures:

Montgomery Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures:

Hamilton Depression Rating Scale (HAMD)

Study Start Date:

March 2005

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239954

Locations

United States, California
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Pharmacology Research Institute
Newport Beach, California, United States, 92660
Pharmacology Research Institute
Northridge, California, United States, 91324
Pharmacology Research Institute
Riverside, California, United States, 92506

Sponsors and Collaborators

Pharmacology Research Institute

Investigators

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00239954 History of Changes
Other Study ID Numbers:	PRI#591 & #592
Study First Received:	October 13, 2005
Last Updated:	April 13, 2006
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 12, 2012