Escitalopram (Lexapro) for Depression MS or ALS

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Major Depression, Multiple Sclerosis, Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br>All patients will receive escitalopram 20 mg daily. | Drug: escitalopram<br>* 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.<br>* Other names: Lexapro;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amyotrophic Lateral Sclerosis, ALS, Multiple Sclerosis, MS, Major Depression, Depression, Major Depressive Disorder, antidepressants, Escitalopram, Lexapro