The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

This study has been terminated.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00151294
First received: September 6, 2005
Last updated: September 12, 2006
Last verified: September 2006
  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 4

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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00151294     History of Changes
Other Study ID Numbers: LXP-MD 45, 0410007546
Study First Received: September 6, 2005
Last Updated: September 12, 2006
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:
Depression
Depressive Disorder
Sclerosis
Multiple Sclerosis
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dexetimide
Citalopram
Antidepressive Agents
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

ClinicalTrials.gov processed this record on September 30, 2014