SSRIs vs. TCAs for Depression in ALS Patients

Depression Clinical Trial

Official title:

An Open-Label Pilot Study Comparing the Efficacy of Selective Serotonin Re-Uptake Inhibitors (SSRIs) Versus Tricyclic Antidepressants (TCAs) for Treating Depression in Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851914
• Other study ID #: 22974
• Status: Completed
• Phase: Early Phase 1
• Start date: July 21, 2015
• Est. completion date: May 30, 2019

Study information

• Verified date: January 2020
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a 12-week, open-label, non-randomized, pilot clinical intervention trial. This is investigator initiated study.This trial will be done at St Louis University ALS clinic. ALS patients will be screened for depression using Beck depression inventory (BDI-II) scale. A mental healthcare provider will evaluate the patients scoring 19 or above, before inclusion in the study. Quality of Life (QOL) assessment by questionnaire (McGill) and ALS functional rating scale (ALS-FRS) measurement will be done at the baseline. Then these patients will be allocated into two treatment groups to receive either TCA or SSRI medication for 12 weeks based on the clinical judgment (non-randomized). Patients will require clinical encounters every 4 weeks and telephone encounters in between the visits to assess the effectiveness of medication and tolerability of the side effects if any. If any patient endorses active suicidal ideation on any of these assessments, he/she will be immediately sent to the ER for appropriate management. At 4, 8 and 12-week clinic visits, repeat BDI, QOL and ALS-FRS measurement will be done on each patient from both groups and used in the data analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Depression
• Depressive Disorder
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• Tricyclic Antidepressants ("TCA")
if patient shows signs of depression they will be placed on one of these medications and seen by a psychiatrist.
• Selective Serotonin Uptake Inhibitors ("SSRI")
if patient shows signs of depression they will be placed on one of these medications and seen by a psychiatrist.

Locations

Country	Name	City	State
United States	Monteleone Hall, Saint Louis University, 1438 South Grand Blvd.	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BDI-II	Primary outcome parameter will be relative change in BDI-II score from baseline to 12 weeks	Baseline to 12 weeks
Secondary	ANCOVA	Analysis of covariance will be used to evaluate for significant differences in BDI-II mean scores between the two treatment groups	12 weeks