Chronic Kidney Disease | Chronic Kidney Disease Antidepressant Sertraline Trial
Chronic Kidney Disease research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Kidney Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:SertralineSertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d
Drug:placeboPlacebo tablet will be identical and matched to sertraline tablet.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
SertralinePatients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
PlaceboPatients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
Start Date: February 8, 2010
Completed Date: November 2017
Phase: Phase 3
Primary Outcome: Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.
Secondary Outcome: 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
Study sponsors, principal investigator, and references
Principal Investigator: Susan S Hedayati, MD MHS
Lead Sponsor: VA Office of Research and Development
Collaborator: University of Texas Southwestern Medical Center
Jain N, Trivedi MH, Rush AJ, Carmody T, Kurian B, Toto RD, Sarode R, Hedayati SS. Rationale and design of the Chronic Kidney Disease Antidepressant Sertraline Trial (CAST). Contemp Clin Trials. 2013 Jan;34(1):136-44. doi: 10.1016/j.cct.2012.10.004. Epub 2012 Oct 22.
Hedayati SS, Gregg LP, Carmody T, Jain N, Toups M, Rush AJ, Toto RD, Trivedi MH. Effect of Sertraline on Depressive Symptoms in Patients With Chronic Kidney Disease Without Dialysis Dependence: The CAST Randomized Clinical Trial. JAMA. 2017 Nov 21;318(19):1876-1890. doi: 10.1001/jama.2017.17131.