Escitalopram (Lexapro) for Depression MS or ALS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965497
• Other study ID #: Pro00003013
• Status: Completed
• Phase: Phase 3
• Start date: July 2009
• Est. completion date: March 2010

Study information

• Verified date: August 2011
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Motor Neuron Disease
• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• escitalopram
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.

Locations

Country	Name	City	State
United States	University of South Carolina School of Medicine	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Ganzini L, Johnston WS, Hoffman WF. Correlates of suffering in amyotrophic lateral sclerosis. Neurology. 1999 Apr 22;52(7):1434-40. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	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).	8 weeks

External Links

•   Click here for more information about this study....Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) and Depression