The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis - Full Text View

Sponsor:	Weill Medical College of Cornell University
Collaborator:	Forest Laboratories
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00151294

Purpose

Emotionally labile, depressed participants with multiple sclerosis treated with escitalopram will have a greater reduction in emotional lability scores and in their psychological distress scores than those who are randomized to receive placebo.

Condition	Intervention	Phase
Depression Multiple Sclerosis	Drug: escitalopram oxalate antidepressant	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression Multiple Sclerosis

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

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

Escitalopram-treated MS patients will have greater reductions in their depressive symptom scores than patients randomized to placebo
Adverse events for both groups will be similar

Secondary Outcome Measures:

Escitalopram-treated emotionally labile patients with MS will have a greater reduction in emotional lability scores than those randomized to placebo.

Estimated Enrollment:	20
Study Start Date:	November 2004
Estimated Study Completion Date:	October 2006

Detailed Description:

Patients with multiple sclerosis who are experiencing mood lability and symptoms of depression will be randomized to receive either escitalopram 10mg/day or placebo tablets for a period of 6 weeks. It is hypothesized that patients receiving medication will experience a greater normalization of their emotional instability and a greater reduction in their depressive symptoms at the end of the six-week trial than those who are not receiving medication.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of multiple sclerosis
Having mild to moderate depressive symptoms, with or without emotional lability
Experiencing psychological distress

Exclusion Criteria:

Meeting DSM-IV diagnostic criteria for Major Depressive Disorder or another Axis 1 diagnosis
Cognitive impairment
The presence of an unstable medical illness that might preclude completion of the study -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151294

Locations

United States, New York
NewYork Presbyterian Hospital
White Plains, New York, United States, 10605

Sponsors and Collaborators

Weill Medical College of Cornell University

Forest Laboratories

Investigators

Principal Investigator:

Barnett S Meyers, MD

Weill Medical College of Cornell University

More Information

No publications provided

Study ID Numbers:	LXP-MD 45, 0410007546
Study First Received:	September 6, 2005
Last Updated:	September 12, 2006
ClinicalTrials.gov Identifier:	NCT00151294 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

Depression (mild to moderate)
Affective symptoms
Emotional lability
Multiple Sclerosis

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Multiple Sclerosis
Pathologic Processes
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation

Dexetimide
Autoimmune Diseases of the Nervous System
Antidepressive Agents
Autoimmune Diseases
Depression
Immune System Diseases
Demyelinating Diseases
Nervous System Diseases
Sclerosis
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists

ClinicalTrials.gov processed this record on November 09, 2009