Phase 3
Completed N=201
Chronic Kidney Disease Antidepressant Sertraline Trial
Source: ClinicalTrials.gov NCT00946998 ↗Enrolled (actual)
201
Serious AEs
13.5%
Results posted
Jan 2018
Primary outcomePrimary: Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score. — -4.1; -4.2 units on a scale — p=0.82
◆ Published Evidence
Highly cited
122citations · ~14 / year
Effect of Sertraline on Depressive Symptoms in Patients With Chronic Kidney Disease Without Dialysis Dependence: The CAST Randomized Clinical Trial.
Summary
This is a randomized double-blinded placebo-controlled trial to see if treatment with sertraline as compared with placebo tablets will improve depression symptoms in patients with chronic kidney disease who have not yet started dialysis or received a kidney transplant. The investigators will also investigate whether sertraline treatment will improve quality of life and whether it is safe to use in patients with kidney disease. The study subject will be randomly assigned to take either sertraline or a placebo tablet for 12 weeks.
Linked Publications (4)
-
Effect of Sertraline on Depressive Symptoms in Patients With Chronic Kidney Disease Without Dialysis Dependence: The CAST Randomized Clinical Trial.
-
Rationale and design of the Chronic Kidney Disease Antidepressant Sertraline Trial (CAST).
-
Association of platelet function with depression and its treatment with sertraline in patients with chronic kidney disease: analysis of a randomized trial.
-
Depression and the Effect of Sertraline on Inflammatory Biomarkers in Patients with Nondialysis CKD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score. |
-4.1; -4.2 | 0.82 |
| 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 |
31; 24; 15; 14 | 0.28 |
| SECONDARY Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale |
-5.0; -3.2 | 0.32 |
| SECONDARY 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. |
0.0; 0.0 | 0.61 |
| SECONDARY Serious Adverse Events During the 12 Week Study Duration. |
0; 0; 7; 5; 8; 7 | >.99 |
Eligibility Criteria
Inclusion Criteria
- Male or female adults aged greater than 21 years.
- Predialysis stages 3, 4 or 5 CKD.
- Current Major Depressive Episode.
- QID-C-16 score of 11.
- Able to understand and sign informed consent.
Exclusion Criteria
- No healthcare power of attorney to sign informed consent.
- Unwilling or unable to participate.
- Kidney transplant recipient.
- Initiated on maintenance dialysis
- Significant hepatic dysfunction or liver enzyme abnormalities 3 times the upper limits of normal.
- Terminal chronic obstructive pulmonary disease or cancer.
- Recent history of active bleeding, such as gastrointestinal bleeding requiring hospitalization 3 months prior
- Current use of class I anti-arrhythmic medications.
- Use of pimozide, MAO inhibitors, reserpine, guanethidine, cimetidine or methyldopa; tri-cyclic anti-depressants, neuroleptics or anti-convulsants, excluding gabapentin
- Use of other serotonergic drugs or supplements such as triptans, tramadol, linezolid, tryptophan, and St. John's Wort.
- Ongoing use of anti-depressants
- Past treatment failure on Sertraline
- Initiation of psychotherapy for depression in the 3 months prior to study entry
- Alcohol or substance abuse or dependence that requires acute detoxification at study entry
- Present or past psychosis or Bipolar I or II disorder
- Dementia or a Mini-Mental State Examination score of <23
- Suicidal ideation
- Pregnancy, lactation and women of childbearing potential not using adequate contraception
Data sourced from ClinicalTrials.gov (NCT00946998) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.