NCT03390933

Identifying and Treating Depression in Hemodialysis Patients

Completed Phase 4 Results posted Last updated 17 October 2024

What this trial tests

Phase 4 trial testing Fluoxetine in Depression in 16 participants. Completed in 28 February 2023.

Timeline

1 March 2018

Primary endpoint
28 February 2023

28 February 2023

Quick facts

Lead sponsor	MetroHealth Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	1 March 2018
Primary completion	28 February 2023
Estimated completion	28 February 2023
Sites	1 location across United States

Drugs / interventions tested

• Fluoxetine (fluoxetine) — full drug profile →

Conditions studied

• Depression — all drugs for Depression →
• Hemodialysis-Induced Symptom — all drugs for Hemodialysis-Induced Symptom →

Sponsor

MetroHealth Medical Center

Who can join

18 and older, any sex, with Depression or Hemodialysis-Induced Symptom. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Directly Observed Weekly Fluoxetine for Major Depressive Disorder Among Hemodialysis Patients: A Single-Arm Feasibility Trial.
   Kauffman KM, Dolata J, Figueroa M, Gunzler D, et al · · 2022 · cited 4× · PMID 35386606 · DOI 10.1016/j.xkme.2022.100413
2. Higher dose weekly fluoxetine in hemodialysis patients: A case series report.
   Kauffman KM, Dolata J, Figueroa M, Gunzler D, et al · · 2021 · cited 2× · PMID 32216496 · DOI 10.1177/0091217420913399