The Efficacy and Safety of Escitalopram for Depression in... | NCT00151294

Studies
The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

NCT00151294

Sponsor

Weill Medical College of Cornell University

Status

Terminated

Last Update Posted

Sep 14, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Depression
Multiple Sclerosis

Interventions

escitalopram oxalate antidepressant

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
0410007546

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Not provided

Completion Date

Oct 2006

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2006

Last Update Posted Date

Sep 14, 2006Estimated

Name	Class
Forest Laboratories	INDUSTRY

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
escitalopram oxalate antidepressant	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barnett S Meyers, MD	Weill Medical College of Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NewYork Presbyterian Hospital		White Plains	New York	10605	United States

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D009103	Multiple Sclerosis
D000342	Affective Symptoms

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided