Escitalopram (Lexapro) for Depression MS or ALS

NCT ID: NCT00965497

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-03-31

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.

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.

Conditions

Major Depression; Multiple Sclerosis; Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Escitalopram

All patients will receive escitalopram 20 mg daily.

Group Type: EXPERIMENTAL

escitalopram

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Lexapro

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Meera Narasimhan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meera Narasimhan, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina School of Medicine

Locations

University of South Carolina School of Medicine

Columbia, South Carolina, United States

Countries

United States

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.

Reference Type: BACKGROUND

PMID: 7582177 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10227631 (View on PubMed)

Other Identifiers

Pro00003013

Identifier Type: -

Identifier Source: org_study_id