Combination of Novel Therapies for CKD Comorbid Depression (CONCORD)

Description

The overall goal of the study is to determine if treatment of a Major Depressive Disorder (MDD) improves the outcomes of patients with chronic kidney disease (CKD). We showed that MDD is present in 25% of CKD patients and independently associated with progression to End-Stage Kidney Disease, hospitalization, and death. Depression is also associated with lower quality of life (QOL), fatigue, poor sleep, and non-adherence to diet and medications. However, evidence for efficacy and tolerability of commonly-used antidepressant medications or nonpharmacologic treatments are limited in CKD patients. Our group was the first to conduct a double-blind randomized controlled trial for MDD treatment in 201 patients with non-dialysis CKD, and showed that sertraline, a commonly used selective serotonin reuptake inhibitor (SSRI), was no more efficacious than placebo for improving depressive symptoms. It becomes imperative to test novel strategies to treat MDD in CKD. We propose to compare with a cont

Trial Eligibility

Inclusion Criteria: 1. Male or female adults aged 18 years or greater. There will be no upper age limit. 2. Presence of CKD stages 3b, 4 or non-dialysis stage 5, with an estimated glomerular filtration rate (GFR) of \<45 mL/min/1.73 m2 for a period of at least 3 months, as defined by the National Kidney Foundation and determined using the four-variable Modification of Diet for Renal Diseases Study formula. 3. Presence of a current Major Depressive Disorder (MDD) based on MINI DSM IV-based criteria 4. Quick Inventory of Depressive Symptomatology-Self-report (QIDS-SR) score of ≥11 at enrollment and ≥11 on QIDS-Clinician Rated (QIDS-C) at randomization. 5. Able to understand and sign informed consent after the nature of the study has been fully explained 6. Kidney transplant patients that are at least 6 month post-transplantation (3 months post-transplant, with at least another 3 months to confirm eGFR \<45) Exclusion Criteria: 1. Unable to understand or give informed consent. 2. Unwilling or unable to participate in the protocol or comply with any of its components 3. Receiving chronic dialysis 4. Significant hepatic dysfunction or liver enzyme abnormalities 3 times or greater than the upper limit of normal 5. Terminal chronic obstructive pulmonary disease or cancer 6. Presence of seizure disorder 7. Current use of class I anti-arrhythmic medications (such as 1C propafenone and flecanide), pimozide, MAO inhibitors, reserpine, guanethidine, cimetidine, or methyldopa; tri-cyclic anti-depressants, neuroleptics, or anti-convulsants 8. Use of serotonergic drugs or supplements such as triptans, tramadol, linezolid, tryptophan, and St. John's Wort. 9. Use of medications known to cause QT prolongation on EKG 10. Ongoing use of antidepressant medications for depression treatment 11. Past treatment failure on bupropion 12. Initiation of depression-focused psychotherapy in the 3 months prior to study entry 13. Active alcohol or substance abuse or dependence that requires acute detoxification at study entry 14. Present or past psychosis or Bipolar I or II disorder 15. Dementia or a Mini-Mental State Examination score \<23 16. Active suicidal intent 17. Pregnancy, lactation, or women of childbearing potential not willing to use adequate contraception

Study Info

Interventions

Locations Recruiting

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