SSRIs vs. TCAs for Depression in ALS Patients
Condition: Depression; Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis; Depression; Depressive Disorder
Study type: Interventional
Phase: Early Phase 1

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.
    

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.
    

Intervention name(s): Tricyclic Antidepressants ("TCA"); Selective Serotonin Uptake Inhibitors ("SSRI")
Intervention type(s): Drug; Drug
Intervention description(s): if patient shows signs of depression they will be placed on one of these medications and seen by a psychiatrist.; if patient shows signs of depression they will be placed on one of these medications and seen by a psychiatrist.
Intervention MeSH terms: Antidepressive Agents; Antidepressive Agents, Tricyclic; Serotonin; Selective Serotonin Reuptake Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment