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Trial record 94 of 119 for:    Neuromuscular Diseases | Recruiting, Not yet recruiting, Available Studies | "Amyotrophic Lateral Sclerosis"

SSRIs vs. TCAs for Depression in ALS Patients

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ClinicalTrials.gov Identifier: NCT02851914
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ghazala Hayat, St. Louis University

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Amyotrophic Lateral Sclerosis Drug: Tricyclic Antidepressants ("TCA") Drug: Selective Serotonin Uptake Inhibitors ("SSRI") Early Phase 1

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 21, 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Active Comparator: Arm 1 - TCA
The Tricyclic Antidepressant ("TCA") group will receive medication for 12 weeks. Patients will be evaluated every 4 weeks and phone call will be made in between visits to assess the effectiveness and side effects of the medication. Questionnaires will be repeated in the clinic visits and will be used in the data analysis to look for improvements and to compare the two classes of medication in this study.
Drug: Tricyclic Antidepressants ("TCA")
if patient shows signs of depression they will be placed on one of these medications and seen by a psychiatrist.

Active Comparator: Arm 2 - SSRI
The Selective Serotonin Reuptake Inhibitor ("SSRI") group will receive medication for 12 weeks. Patients will be evaluated every 4 weeks and phone call will be made in between visits to assess the effectiveness and side effects of the medication. Questionnaires will be repeated in the clinic visits and will be used in the data analysis to look for improvements and to compare the two classes of medication in this study.
Drug: 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.




Primary Outcome Measures :
  1. BDI-II [ Time Frame: Baseline to 12 weeks ]
    Primary outcome parameter will be relative change in BDI-II score from baseline to 12 weeks


Secondary Outcome Measures :
  1. ANCOVA [ Time Frame: 12 weeks ]
    Analysis of covariance will be used to evaluate for significant differences in BDI-II mean scores between the two treatment groups



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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851914


Contacts
Contact: Ghazala s Hayat, MD 314-977-4800 hayatm2@slu.edu
Contact: Gayatriben Gadani, MD 314-977-4800 gadanig@slu.edu

Locations
United States, Missouri
Monteleone Hall, Saint Louis University, 1438 South Grand Blvd. Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Cindy M Roseman, LPN    314-977-4829    crosema3@slu.edu   
Contact: Peggy A Suzor    314-977-4822    guinnpa@slu.edu   
Sponsors and Collaborators
St. Louis University
Investigators
Study Chair: Sean E Goretzke, MD St. Louis University

Responsible Party: Ghazala Hayat, Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT02851914     History of Changes
Other Study ID Numbers: 22974
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Depressive Disorder
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Mood Disorders
Mental Disorders
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Metabolic Diseases
Depression
Sclerosis
Behavioral Symptoms
Pathologic Processes
TDP-43 Proteinopathies
Proteostasis Deficiencies
Antidepressive Agents
Serotonin
Antidepressive Agents, Tricyclic
Serotonin Uptake Inhibitors
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators