Major Depression in ALS
University of South Carolina School of Medicine

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

Background: Depression is highlighted as a common, treatable problem in palliative care but often goes unrecognized and untreated. Estimates of the occurrence of depression in long-term and severe illness vary from 15-50%. People with ALS face disease progression with ongoing changes and losses that can lead to depression.  Early recognition and treatment of depression serve to enhance ability to adapt to losses and significantly improve quality of life.

Researchers at USC School of Medicine, led by Dr. Meera Narasimhan, are conducting a study evaluating the effectiveness of escitalopram (Lexapro®) in the treatment of Major Depression in ALS. Escitalopram is a FDA approved medication for Major Depressive Disorder. Our Research Team intends to assess its effectives in patients with ALS and Depression.

Study Details: Participation in this study will require at least 2 visits to the University Specialty Clinics Research Office located near Palmetto Health Richland Hospital in Columbia, SC. On the first visit, participants will have lab work, an EKG, a physical with neurological exam and a mental health evaluation to insure they qualify for the study and are healthy enough to participate. Once a participant is eligible, they will receive medication and complete tests designed to measure their progress every week for the duration of the 8-week study. At the last visit, week 8, the participant will return to the Research office for a final neurological exam and progress measurements. Once the study is complete participants who responded to the antidepressant (escitalopram) will be assessed to continue the medication. Researchers will work with the primary care provider of participants who do not respond to recommend another antidepressant. Participants will continue care with their primary physician.

The primary objective of this study is to assess the effectiveness (efficacy and tolerability) of escitalopram (Lexapro®) in improving symptoms of Major Depression in patients with Amyotrophic Lateral Sclerosis (ALS). The secondary objective is to assess improvement in the quality of life in patients with Major Depression and ALS following treatment with escitalopram.

Inclusion Criteria:

• Symptoms of depression including: Sleep difficulty, loss of interest in people and things around you, feelings of guilt, lack of energy, difficulty concentrating, appetite changes, irritability and feelings that life is not worth living.
• Ages 18-70
• Diagnosis of non-psychotic Major Depression (determined at screening visit)
• Diagnosis of ALS

Exclusion Criteria:

• Previous diagnosis of a psychotic disorder or Bipolar Disorder
• Alcohol or illicit drug abuse within the previous 6 months
• Currently taking Celexa® (citalopram) or escitalopram
• History of unstable medical disorder or pregnancy

Enrollment Status: Open

Target  Enrollment: 15

Contact Information:
Frank Ballard, MA or Suzanne Hardeman, PMHNP-BC  Coordinators
University of South Carolina School of Medicine
Department of Neuropsychiatry and Behavioral Science
Office of Biological Research
3555 Harden Street Extension  Suite 301
Columbia, South Carolina
Phone: 803-434-1100
Fax: 803-434-1042
fballard@uscmed.sc.edu  or shardeman@uscmed.sc.edu