Escitalopram (Lexapro) for Depression MS or ALS

NCT00965497 | Completed Phase 3 Results DMC

• 1 other identifier: Pro00003013
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression; Multiple Sclerosis; Amyotrophic Lateral Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• McGill Quality of Life Scale (MQOL)

  8 weeks

Study Arms (1)

Escitalopram

EXPERIMENTAL

All patients will receive escitalopram 20 mg daily.

Drug: escitalopram

Interventions

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.

Also known as: Lexapro

Escitalopram

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina School of Medicine

Columbia, South Carolina, 20203, United States

Location

Related Publications (2)

• 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.

  PMID: 7582177 BACKGROUND

• 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.

  PMID: 10227631 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Multiple Sclerosis; Amyotrophic Lateral Sclerosis; Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Meera Narasimhan, MD
• Organization: University of South Carolina School of Medicine

shardeman@uscmed.sc.edu

803-434-1100

Study Officials

• Meera Narasimhan, MD

  University of South Carolina School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 25, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 1, 2019
• Results First Posted: September 7, 2011

Record last verified: 2011-08

Locations

US (1)