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NCT02358343 · ClinicalTrials.gov registry record · Phase 3
A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND}
A Phase 3 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 3
- Development phase
- 184
- Enrollment target
NCT02358343 is a Phase 3 study that has completed, run by University of Washington. The registered enrollment target is 184 participants.
The verdict
NCT02358343, a Phase 3 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 184 participants
- Enrollment target
Study 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. Succ
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy
- BEHAVIORAL Engagement Interview
- DRUG Antidepressant Drug Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2015-03-23 |
| Est. Completion | 2017-12-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02358343
The ClinicalTrials.gov registry entry for NCT02358343 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cognitive Behavioral Therapy is the first listed.
NCT02358343 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02358343 about?
NCT02358343 is a clinical study titled "A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND}". 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 tre...
What is the current status of trial NCT02358343?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 184 participants. The study started on 2015-03-23. Estimated completion is 2017-12-15.
What interventions are being tested in trial NCT02358343?
The interventions under investigation include: Cognitive Behavioral Therapy (BEHAVIORAL), Engagement Interview (BEHAVIORAL), Antidepressant Drug Therapy (DRUG).
Who is sponsoring clinical trial NCT02358343?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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