SSRIs vs. TCAs for Depression in ALS Patients

Completed · Early Phase 1

Conditions studied: Depression, Amyotrophic Lateral Sclerosis

In brief

Depression is seen in 9-11% of ALS patients and adequate and proper treatment is needed. In this study, ALS patients will be screened for depression using self-reported multiple choice questionnaire. Patients who fulfill the criteria for depression based on this screening tool will be evaluated by psychiatrist before inclusion in the study. The investigators will also measure quality of life and functional status by simple questionnaires. The patients will be allocated into two treatment groups to receive either TCA or SSRI for 12 weeks. Patients will be evaluated every 4 weeks and phone calls will be made in between the visits if needed to assess about efficacy and any side effects. If any patient reports having suicidal thoughts on any of these phone calls or clinic visits, he/she will be immediately sent to the ER for appropriate management. The investigators will repeat the questionnaires in the clinic visits, and use them in the data analysis to look for any improvement and to compare the two medication classes used in this study. This data may be used later on to do larger studies and help to make standard recommendations in treating depression in ALS patients.

Key facts

Study ID

NCT02851914

Run by

St. Louis University

People needed

2

Starts

2015-07-21

Expected to finish

2019-05-30

Last updated by the study team

2020-01-14

Who can join

Age: 25 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of definite or probable ALS
• Informed and written consent for enrollment in study
• Gender: both male and female
• Age: 25-80 years
• BDI score 19 or above
• Depression diagnosis by mental health provider

You may not qualify if…

• History of psychotic disorder, premorbid bipolar depression
• ALS-FRS score < 26
• Cognitive impairment
• Currently on SSRIs or TCAs. However if for some reason they are off their treatment, then they can be enrolled in the study after a washout period of 30 days.
• Currently on other antidepressants such as monoamine oxidase inhibitors (MAOIs), selective norepinephrine re-uptake inhibitors (SNRIs) etc.

Where it is running

• Monteleone Hall, Saint Louis University, 1438 South Grand Blvd. — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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