Escitalopram (Lexapro) for Depression MS or ALS
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Hamilton Depression Scale (HAM-D 17). | Mean Difference (Final Values) 95 | 0.01 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Escitalopram
Results by group
Hamilton Depression Scale (HAM-D 17).
8 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Escitalopram | 15 depression severity | 7 (Standard Deviation) | 13 |
p = 0.01; Mean Difference (Final Values) 95
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Open-label, Single Arm | 14 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Hamilton Depression Scale (HAM-D 17).
8 weeks
Mood and sleep
Other measures (1)
McGill Quality of Life Scale (MQOL)
8 weeks
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 70
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.
Papers
Background
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.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.
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History
Started
Jul 2009
Main results due
Mar 2010
Finished
Mar 2010
Results posted
Sept 2011
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