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临床试验/NCT02851914
NCT02851914已完成早期 1 期

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

St. Louis University1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年7月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
2
试验地点
1
主要终点
BDI-II

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Arm 1 - TCA

Active Comparator

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.

干预措施: Tricyclic Antidepressants ("TCA") (Drug)

Arm 2 - SSRI

Active Comparator

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.

干预措施: Selective Serotonin Uptake Inhibitors ("SSRI") (Drug)

结局指标

主要结局

BDI-II

时间窗: Baseline to 12 weeks

Primary outcome parameter will be relative change in BDI-II score from baseline to 12 weeks

次要结局

  • ANCOVA(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghazala Hayat

Professor

St. Louis University

研究点 (1)

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