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Completed

NCT Number: NCT00965497

Escitalopram (Lexapro) for Depression MS or ALS

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

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Key information

Conditions

Major Depression Amyotrophic Lateral Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Central Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Depressive Disorder Depressive Disorder, Major Immune System Diseases Mental Disorders Metabolic Diseases Mood Disorders Motor Neuron Disease Multiple Sclerosis Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of South Carolina School of Medicine

Columbia, South Carolina, 20203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram

Drug

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 names: Lexapro

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 25, 2009
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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