A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND}
Status:
Completed
Trial end date:
2017-12-15
Target enrollment:
Participant gender:
Summary
Patients whose kidneys fail generally require dialysis treatments to sustain life. The
ability of patients to make major adjustments in their lives for dialysis is hampered by
depression that affects almost one-quarter of such individuals. There are no studies that
have adequately tested whether treatment of depression is effective in dialysis patients and
if there is any difference between the response to the two most commonly available forms of
treatment, psychotherapy and anti-depressant drug therapy.
To fill this important gap in the investigators knowledge, the investigators propose to
undertake (1) a randomized controlled clinical trial of 200 patients to test whether an
engagement interview will result in a higher proportion of dialysis patients accepting
treatment for depression; and (2) a randomized controlled clinical trial of 120 patients to
determine whether there is any difference in the likelihood of improvement of depressive
symptoms with psychotherapy or drug therapy among dialysis patients with depression. Patients
in these studies will be enrolled from among individuals receiving care in 50 dialysis
facilities in three metropolitan areas - Seattle, Dallas, and Albuquerque. The research
proposal has been developed with the support of patients, caregivers, and stakeholders to
ensure that the findings from the study are relevant to them and can be readily implemented
in day-to-day clinical practice. Hence, the engagement interview and psychotherapy will be
delivered in a dialysis facility to ease the burden on patients, and the dose of the study
drug will be changed in partnership with the study participants. In addition to depressive
symptoms, the effect of treatment on other meaningful outcomes such as fatigue and sleep will
be determined.
The two forms of treatment for depression being tested in this clinical trial are very
different from each other and patients differ with regards to the treatment option preferable
and/or available to them. Successful completion of the clinical trial will provide patients,
caregivers, and other stakeholders with the information that they would need when faced with
a diagnosis of depression in patients undergoing hemodialysis. This will allow patients to
select evidence-based treatments to improve outcomes that are relevant to them.
Phase:
Phase 3
Details
Lead Sponsor:
University of Washington
Collaborators:
Patient-Centered Outcomes Research Institute University of New Mexico University of Texas