Major DepressionPhase 3NCT00965497

Escitalopram (Lexapro) for Depression MS or ALS

A Phase 3 study testing escitalopram in people with Major Depression and Multiple Sclerosis, run by University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Major Depression, Multiple Sclerosis, Amyotrophic Lateral Sclerosis
What is being tested?: escitalopram
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: Jul 2009to Mar 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients between 18 and 70 years of age with documented ALS or MS,
DSM-IV episode of non-psychotic Major Depression,
≥14 score on the 17-item HAM-D,
Ability to give informed consent.

Who cannot join

History of psychotic disorders,
Psychotic depression,
Bipolar depression,
Suicide risk,
History of substance abuse in the previous 6 months,
History of unstable medical disorders,
Pregnancy or planning for pregnancy,
Severity of ALS or MS that limits participating in the study protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of South Carolina School of Medicine
Columbia, South Carolina, 20203

Other trials in United States

About this study

Official title: An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis

The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.

Read the detailed description

This eight-week study aims to assess the effectiveness and tolerability of escitalopram in improving symptoms of Major Depression in patients with Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) as measured by the HAM-D. In addition, the study will assess improvement in the quality of life in patients with Major Depression and ALS or MS.

Conditions: Major Depression, Multiple Sclerosis, Amyotrophic Lateral Sclerosis
Being tested: escitalopram
Keywords: Amyotrophic Lateral Sclerosis, ALS, Multiple Sclerosis, MS, Major Depression, Depression, Major Depressive Disorder, antidepressants, Escitalopram, Lexapro
Medical subject headings: Depressive Disorder, Major, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

escitalopramDrug
Also called Lexapro
After confirmation of diagnoses and safety screening escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability. No other psychotropic medications will be permitted during the study. Medications for coexisting medical problems (e.g. hypertension) will be permitted. Study visits will include weekly visits for first 2 weeks and biweekly visits for next 6 weeks. Medications will be dispensed weekly or biweekly and the participants will be followed for 8 weeks.

Study groups in NCT00965497
Study group	Role	What they receive
Escitalopram	Experimental	All patients will receive escitalopram 20 mg daily. Receives: Drug: escitalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

Hamilton Depression Scale (HAM-D 17).
Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression.
Measured: 8 weeks

Secondary outcomes (1)

McGill Quality of Life Scale (MQOL)
McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent).
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Mar 2010

First posted25 Aug 2009 (estimated)
Study startJul 2009
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Major DepressionStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00965497
Sponsor's protocol ID: Pro00003013
Status last verified: Aug 2011
First submitted: 7 Aug 2009
Last updated: 1 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Cohen SR, Mount BM, Strobel MG, Bui F. The McGill Quality of Life Questionnaire: a measure of quality of life appropriate for people with advanced disease. A preliminary study of validity and acceptability. Palliat Med. 1995 Jul;9(3):207-19. doi: 10.1177/026921639500900306.
PubMed 7582177
Ganzini L, Johnston WS, Hoffman WF. Correlates of suffering in amyotrophic lateral sclerosis. Neurology. 1999 Apr 22;52(7):1434-40. doi: 10.1212/wnl.52.7.1434.
PubMed 10227631

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis
ClinicalTrials.gov ID: NCT00965497
Acronym / sponsor ID: Pro00003013
Conditions: Major Depression, Multiple Sclerosis, Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis, ALS, Multiple Sclerosis, MS, Major Depression, Depression, Major Depressive Disorder, antidepressants
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: University of South CarolinaUniversity, hospital or other
Study start: Jul 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 25 Aug 2009 (estimated)
Results: Posted 7 Sep 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Escitalopram	Experimental	Drug: escitalopramAll patients will receive escitalopram 20 mg daily.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients between 18 and 70 years of age with documented ALS or MS,
DSM-IV episode of non-psychotic Major Depression,
≥14 score on the 17-item HAM-D,
Ability to give informed consent.

Key exclusion criteria (8 listed)

History of psychotic disorders,
Psychotic depression,
Bipolar depression,
Suicide risk,
History of substance abuse in the previous 6 months,

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
escitalopramAlso: LexaproAfter confirmation of diagnoses and safety screening escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability. No other psychotropic medications will be permitted during the study. Medications for coexisting medical problems (e.g. hypertension) will be permitted. Study visits will include weekly visits for first 2 weeks and biweekly visits for next 6 weeks. Medications will be dispensed weekly or biweekly and the participants will be followed for 8 weeks.	Drug	Escitalopram

Primary outcome

Hamilton Depression Scale (HAM-D 17).
Time frame: 8 weeks
Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression.

1 secondary outcome

McGill Quality of Life Scale (MQOL)
Time frame: 8 weeks

Results and safety

Results posted to the registry on 7 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open-label, Single Arm	14	13

Primary outcome: Hamilton Depression Scale (HAM-D 17).

Time frame: 8 weeks. Median (Standard Deviation). Unit: depression severity

Measure	Escitalopram n = 13
Value	15 (7)

Escitalopram: Mean Difference (Final Values): 95, p = 0.01, t-test, 2 sided

Population analysed: Intention to Treat

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open-label, Single Arm	0 of 14 (0%)	5 of 14 (35.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 7582177Cohen SR, Mount BM, Strobel MG, Bui F. The McGill Quality of Life Questionnaire: a measure of quality of life appropriate for people with advanced disease. A preliminary study of validity and acceptability. Palliat Med. 1995 Jul;9(3):207-19. doi: 10.1177/026921639500900306.
Background: PubMed 10227631Ganzini L, Johnston WS, Hoffman WF. Correlates of suffering in amyotrophic lateral sclerosis. Neurology. 1999 Apr 22;52(7):1434-40. doi: 10.1212/wnl.52.7.1434.

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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.

Meera Narasimhan, MD principal investigator

University of South Carolina School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing escitalopram in people with Major Depression and Multiple Sclerosis, run by University of South Carolina 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 1 May 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hamilton Depression Scale (HAM-D 17). (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00965497, which also lists 2 linked publications.

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 1 May 2019.