| Trial ID: | L0386 |
| Source ID: | NCT00946998
|
| Associated Drug: |
Sertraline
|
| Title: |
Chronic Kidney Disease Antidepressant Sertraline Trial
|
| Acronym: |
CAST
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00946998/results
|
| Conditions: |
Chronic Kidney Disease|Depression
|
| Interventions: |
DRUG: Sertraline|DRUG: placebo
|
| Outcome Measures: |
Primary: Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score., The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression., baseline to 12 weeks | Secondary: Response to Treatment Defined as a Decline of 50% in the Baseline QIDS-C-16 Score and Remission of Depression Defined as a QIDS-C-16 Score of 5, The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression., baseline to 12 weeks|Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale, Each item is rated on a 0 to 8 Likert scale with 0 indicating no impairment and 8 indicating severe impairment and a total score range of 0 to 40., baseline to 12 weeks|Change in Quality of Life From Baseline to Exit in the Kidney Disease Quality of Life -Short Form, Version 1.3, Patient-reported Overall Health., Raw scores from version 1.3 were transformed to a scale from 0 to 100, in which higher numbers signify more favorable quality of life., baseline to 12 weeks|Serious Adverse Events During the 12 Week Study Duration., death, dialysis initiation, hospitalizations, or bleeding requiring transfusion, during 12 week study duration
|
| Sponsor/Collaborators: |
Sponsor: VA Office of Research and Development | Collaborators: University of Texas Southwestern Medical Center|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
201
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-02-08
|
| Completion Date: |
2017-11
|
| Results First Posted: |
2018-01-30
|
| Last Update Posted: |
2018-03-09
|
| Locations: |
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas, Texas, 75216, United States|University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, 75390, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00946998
|
