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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: Patient-Centered Outcomes Research Institute; University of New Mexico; University of Texas
• Treatments: Antidepressive Agents; Sertraline

Criteria

Inclusion Criteria:

1. Age ≥ 21 years;

2. Undergoing thrice-weekly maintenance HD for ≥ 3 months;

3. Able to speak either English or Spanish;

4. BDI-II score ≥ 15; and

5. Meets diagnostic criteria for either current major depressive episode or dysthymia on the MINI.

Exclusion Criteria:

1. Active suicidal intent;

2. Ongoing psychotherapy or current treatment with certain anti-depressant drugs;

3. Evidence of cognitive impairment on Mini-Cog;

4. Present or past psychosis or bipolar disorder I or II on the MINI;

5. Alcohol or substance abuse diagnosed on the MINI or history of such abuse in the past three months;

6. Life expectancy < 3 months, in the judgment of the site principal investigator;

7. Anticipated to receive living related donor kidney transplantation within 3 months;

8. Pregnancy, or lactation, or women of childbearing age not willing to use adequate birth control;

9. Clinical and/or laboratory evidence of chronic liver disease;

10. History of significant active bleeding in the past three months, such as hospitalization for gastrointestinal bleeding;

11. Current use of class I anti-arrhythmic medications (e.g., propafenone, flecainide), pimozide, monoamine oxidase inhibitors, reserpine, guanethidine, cimetidine, tri-cyclic anti-depressants, triptans, tramadol, linezolid, tryptophan, and St. John's wort; and

12. Known hypersensitivity to sertraline.