Escitalopram (Lexapro) for Depression MS or ALS

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2010

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.

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of South Carolina
  • Provider of Information About this Clinical Study
    • Principal Investigator: Meera Narasimhan, Professor – University of South Carolina
  • Overall Official(s)
    • Meera Narasimhan, MD, Principal Investigator, University of South Carolina School of Medicine

References

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.

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.

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