DepressionPhase 4NCT00151294
The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis
A Phase 4 study testing escitalopram oxalate antidepressant in people with Depression and Multiple Sclerosis, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Multiple Sclerosis
- What is being tested?
- escitalopram oxalate antidepressant
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Oct 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of multiple sclerosis
- Having mild to moderate depressive symptoms, with or without emotional lability
- Experiencing psychological distress
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork Presbyterian Hospital
White Plains, New York, 10605
About this study
Official title: A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis
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.
Read the 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.
- Conditions
- Depression, Multiple Sclerosis
- Being tested
- escitalopram oxalate antidepressant
- Keywords
- Depression (mild to moderate), Affective symptoms, Emotional lability, Multiple Sclerosis
- Medical subject headings
- Depression, Multiple Sclerosis, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopram oxalate antidepressantDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (1)
Escitalopram-treated emotionally labile patients with MS will have a greater reduction in emotional lability scores than those randomized to placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startNov 2004
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Investigators
- Barnett S Meyers, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151294
- Sponsor's protocol ID
- LXP-MD 45
- Other IDs
- 0410007546
- Status last verified
- Sep 2006
- First submitted
- 6 Sep 2005
- Last updated
- 14 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00151294
- Acronym / sponsor ID
- LXP-MD 45
- Conditions
- Depression, Multiple Sclerosis
- Keywords
- Depression (mild to moderate), Affective symptoms, Emotional lability, Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Nov 2004
- Study completion
- Oct 2006
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of multiple sclerosis
- Having mild to moderate depressive symptoms, with or without emotional lability
- Experiencing psychological distress
Key exclusion criteria (3 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| escitalopram oxalate antidepressant | Drug | – |
Primary outcome
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
1 secondary outcome
Escitalopram-treated emotionally labile patients with MS will have a greater reduction in emotional lability scores than those randomized to placebo.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barnett S Meyers, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing escitalopram oxalate antidepressant in people with Depression and Multiple Sclerosis, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Escitalopram-treated MS patients will have greater reductions in their depressive symptom scores than patients randomized to placebo. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2006.