Escitalopram (Lexapro) for Depression MS or ALS

• ClinicalTrials.gov Identifier: NCT00965497
• Recruitment Status: Completed
• First Posted: August 25, 2009
• Results First Posted: September 7, 2011
• Last Update Posted: May 1, 2019
• Sponsor: University of South Carolina
• Information provided by (Responsible Party): Meera Narasimhan, University of South Carolina

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Major Depression; Multiple Sclerosis; Amyotrophic Lateral Sclerosis	Drug: escitalopram	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis
• Study Start Date: July 2009
• Actual Primary Completion Date: March 2010
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm

Intervention/treatment

Experimental: Escitalopram; All patients will receive escitalopram 20 mg daily.

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.; Other Name: Lexapro

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. McGill Quality of Life Scale (MQOL) [ Time Frame: 8 weeks ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, South Carolina

University of South Carolina School of Medicine

Columbia, South Carolina, United States, 20203

Sponsors and Collaborators

University of South Carolina

Investigators

• Principal Investigator: Meera Narasimhan, MD; University of South Carolina School of Medicine

More Information

Additional Information:

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

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.

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

• Responsible Party: Meera Narasimhan, Professor, University of South Carolina
• ClinicalTrials.gov Identifier: NCT00965497
• Other Study ID Numbers: Pro00003013
• First Posted: August 25, 2009
• Results First Posted: September 7, 2011
• Last Update Posted: May 1, 2019
• Last Verified: August 2011

Keywords provided by Meera Narasimhan, University of South Carolina:

Amyotrophic Lateral Sclerosis; ALS; Multiple Sclerosis; MS; Major Depression; Depression; Major Depressive Disorder; antidepressants; Escitalopram; Lexapro

Additional relevant MeSH terms:

Citalopram; Multiple Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis; Depression; Depressive Disorder; Depressive Disorder, Major; Behavioral Symptoms; Mood Disorders; Mental Disorders; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurodegenerative Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents