Abstract: FR-OR110
CONCORD: A Randomized Controlled Trial of Novel Therapies for Depression in Patients with CKD
Session Information
- Late-Breaking Research Orals: AKI, CKD, CKM, and More
October 23, 2026 | Location: Four Seasons Ballroom 2, Convention Center
Abstract Time: 04:54 PM - 05:06 PM
Category: CKD (Non-Dialysis)
- 2202 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Hedayati, Susan, Stony Brook University, Stony Brook, New York, United States
- McAdams, Meredith C., The University of Texas Southwestern Medical Center, Dallas, Texas, United States
- Gregg, Lucile Parker, Michael E DeBakey VA Medical Center, Houston, Texas, United States
- Carmody, Thomas, The University of Texas Southwestern Medical Center, Dallas, Texas, United States
- Goodman, Lynnel, The University of Texas Southwestern Medical Center, Dallas, Texas, United States
- Dubovsky, Amelia, University of Washington, Seattle, Washington, United States
- Abdulrahman, Rula A., Stony Brook University, Stony Brook, New York, United States
- Roehm, Bethany Angela, The University of Texas Southwestern Medical Center, Dallas, Texas, United States
- Shastri, Shani, The University of Texas Southwestern Medical Center, Dallas, Texas, United States
- Zhang, Xiaoyue, Stony Brook University, Stony Brook, New York, United States
- Tuttle, Katherine R., University of Washington, Seattle, Washington, United States
- Trivedi, Madhukar, The University of Texas Southwestern Medical Center, Dallas, Texas, United States
- Mehrotra, Rajnish, University of Washington, Seattle, Washington, United States
Background
Major depressive disorder (MDD) is prevalent in CKD. Traditional treatments as monotherapy had limited efficacy, necessitating studies of novel therapies.
Methods
In a multicenter randomized, doubleblind, controlled 16-week trial, 4360 people with CKD G3b-G5D were screened with the Quick Inventory of Depression Symptomatology (QIDS). 202 patients with MDD were randomized to 3 parallel arms: Strategy 1, behavioral activation therapy (BAT)/placebo; Strategy 2, bupropion-XL 150 mg daily/clinical management control (CM); Control, placebo/CM. Strategies began with monotherapy with bupropion or BAT and escalated to a combination of both if MDD remission was not achieved at 8 weeks. The primary outcome was change in MDD severity from baseline to week 16 in QIDS. Secondary outcomes were change from baseline to week 8 and safety.
Results
Intention-to-treat analysis included 201 (CKD G3b, G4, G5ND, and G5D: 36%, 43%, 11%, 10%) with ≥1 post-randomization QIDSC. Mean±SD baseline QIDS score was 14.3±2.6 in Strategy 1 (N=70), 14.8±3.0 in Strategy 2 (N=68) and 15.0±3.0 in control (N=63). Mean (SD) participation time was 15.2 (2.7) weeks, not different between arms. At week 16, QIDS score changed from baseline by -5.9, 95% CI (-7.0, -4.7) in Strategy 1, -5.7 (-6.7, -4.6) in Strategy 2, and -5.9 (-6.9, -4.9) in control (Strategy 1 vs control: repeated measures arm effect p=.4; arm by week effect p=.2; Strategy 2 vs control: arm effect p=.003, arm by week p=.01) (Figure). At 8 weeks, the QIDS changed by -5.4, 95% CI (-6.6, -4.3) in Strategy 1, -3.8 (-4.7, -3.0) in Strategy 2, and -4.9 (-5.9, -4.0) in control (Strategy 1 vs Control: arm effect p=.003, arm by week p=.01; Strategy 2 vs Control: arm effect p=.02, arm by week p=.3). 6 vs. 26% in Strategy 2 vs 1 achieved remission at 8 weeks, p=.002. Insomnia (13 vs 3%, p=.03) and confusion (7 vs 0%, p=.03) were more frequent with Strategy 2 vs 1.
Conclusion
In CKD patients, there was greater improvement in MDD symptoms with BAT compared to control at 8 weeks. At 16 weeks, Strategy 1 or 2 were not superior to control for treatment of MDD.
Acknowledgment
Funding: R01DK124379
Funding
- NIDDK Support