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NCT02851914 · ClinicalTrials.gov registry record · Early Phase 1
SSRIs vs. TCAs for Depression in ALS Patients
A Early Phase 1 study, sponsored by St. Louis University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
NCT02851914 is a Early Phase 1 study that has completed, run by St. Louis University. The registered enrollment target is 2 participants.
The verdict
NCT02851914, a Early Phase 1 study, has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Tricyclic Antidepressants ("TCA")
- DRUG Selective Serotonin Uptake Inhibitors ("SSRI")
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-07-21 |
| Est. Completion | 2019-05-30 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02851914
The ClinicalTrials.gov registry entry for NCT02851914 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tricyclic Antidepressants ("TCA") is the first listed.
NCT02851914 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02851914 about?
NCT02851914 is a clinical study titled "SSRIs vs. TCAs for Depression in ALS Patients". 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 p...
What is the current status of trial NCT02851914?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2015-07-21. Estimated completion is 2019-05-30.
What interventions are being tested in trial NCT02851914?
The interventions under investigation include: Tricyclic Antidepressants ("TCA") (DRUG), Selective Serotonin Uptake Inhibitors ("SSRI") (DRUG).
Who is sponsoring clinical trial NCT02851914?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
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