Identifying and Treating Depression in Hemodialysis Patients
Status:
Recruiting
Trial end date:
2023-11-30
Target enrollment:
Participant gender:
Summary
Depression is present in about 20-30% of hemodialysis patients and is associated with
morbidity and mortality. However, depression is inadequately diagnosed and treated among
dialysis patients. This is due in part to the overlap between depressive symptoms (e.g.
appetite change, trouble sleeping, feeling tired) and symptoms related to persistent
metabolic derangements in hemodialysis patients (e.g. nausea, nocturnal cramps, feeling
washed out after treatment). The overlap between depressive symptoms and dialysis-related
complications makes it difficult to diagnose and therefore to treat depression. In addition,
prescription of antidepressant medication may increase an already high pill burden and result
in poor adherence. Moreover, the evidence base to guide depression treatment among
hemodialysis patients is limited. In the investigators' previous work, they developed methods
to use latent variables and structural equation modeling to isolate depressive symptoms.
Other investigators have demonstrated that directly observed treatment enhances the
effectiveness of tuberculosis and HIV treatment.
Investigators now propose a cross-sectional study (Phase 1) followed by a single-arm clinical
trial (Phase 2) at 17 dialysis facilities. The cross-sectional study will involve assessments
of depressive symptoms (using the PHQ-9 screening instrument) as well as dialysis-related
complications, anxiety, and quality of life (Quality of Life Questionnaire) in about 1083
patients. Investigators will then use structural equation modeling to develop and validate a
hemodialysis-specific PHQ-9 (hdPHQ-9) that will isolate depressive symptoms. The trial will
involve 96 patients with confirmed depression who will be assigned to directly observed
weekly antidepressant treatment with fluoxetine. The primary outcome of the trial will be
remission of depression at 12 weeks. The trial results will also be used to compare the
responsiveness of the PHQ-9 and the hdPHQ-9. Investigators anticipate that the hdPHQ-9 will
be a valid and responsive instrument that will isolate depressive symptoms in hemodialysis
patients and ultimately improve the screening and diagnosis of depression. Investigators also
expect that directly observed weekly fluoxetine treatment will be an effective way to manage
depression among hemodialysis patients.