A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND}
Condition: Depression; End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Depression; Depressive Disorder
Intervention: Engagement Interview; Cognitive Behavioral Therapy; Antidepressant Drug Therapy
Intervention description: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.; Cognitive Behavioral Therapy (CBT) is a short-term psychotherapy that will focus on how the individual is thinking, behaving, and communicating today rather than on their childhood experience. The therapist will assist the patient in identifying specific distortions (cognitive assessment) and biases in thinking and will provide guidance on how to change this thinking. During the course of intervention, study subjects will undergo assessment of severity of depressive symptoms using Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) every two weeks for the first six weeks (weeks 0, 2, 4, and 6) and every three weeks for the next six weeks (weeks 9 and 12).; The site investigators will prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration will be implemented using standardized assessments of depressive symptoms and drug side effects; and the research team and the patient make joint decisions to maintain, increase, or decrease the dose. This will help establish the highest effective but tolerable dose tailored for each patient. The QIDS-SR scale will be used to assess the clinical response for dose titration. The FIBSER scale will be used to assess side effects and the degree to which they interfere with day-to-day functions. The participant-specific dose at week 6, up to a maximum of 200 mg/d, will be continued for the remaining 6 weeks.
Intervention MeSH terms: Sertraline; Antidepressive Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Comorbid Depression; Major Depressive Disorder; Dysthymia; Cognitive Behavioral therapy (CBT); Sertraline; Engagement Interview; End Stage Renal Disease (ESRD); Hemodialysis

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.
    

Eligibility 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.