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| ID | Type | Description | Link |
|---|---|---|---|
| 1I01CX000217-01 | U.S. NIH Grant/Contract | View source | |
| 1R01DK085512-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Texas Southwestern Medical Center | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
This is a randomized double-blinded placebo-controlled trial of adults with predialysis stages 3-5 Chronic Kidney Disease and Major Depressive Episode. Subjects will be randomized in a double-blind fashion to placebo or sertraline (beginning at 50 mg/d and escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d) and followed for 12 weeks. The primary outcome is to investigate if treatment with sertraline, as compared with placebo, results in an improvement in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology Clinician Rated (QIDS-C-16) score. Secondary outcomes include whether sertraline, as compared with placebo, improves overall function and quality of life and whether it will result in more serious adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertraline | Active Comparator | Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode |
|
| Placebo | Placebo Comparator | Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline | Drug | Sertraline 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan S Hedayati, MD MHS | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas | 75216 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23085503 | Result | 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. | |
| 29101402 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sertraline | Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode Sertraline: Sertraline 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 |
| FG001 | Placebo | Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode placebo: Placebo tablet will be identical and matched to sertraline tablet. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sertraline | Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode Sertraline: Sertraline 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | baseline to 12 weeks |
|
12 weeks of randomized study duration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sertraline | Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode Sertraline: Sertraline 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dialysis initiation | Renal and urinary disorders | Systematic Assessment | Initiation of chronic dialysis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea, indigestion, or vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Hedayati, MD, Professor of Medicine | University of Texas Southwestern Medical Center | 214-645-6106 | susan.hedayati@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| placebo | Drug | Placebo tablet will be identical and matched to sertraline tablet. |
|
| 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 |
| University of Texas Southwestern Medical Center at Dallas |
| Dallas |
| Texas |
| 75390 |
| United States |
| 35368605 | Derived | Gregg LP, Carmody T, Le D, Bharadwaj N, Trivedi MH, Hedayati SS. Depression and the Effect of Sertraline on Inflammatory Biomarkers in Patients with Nondialysis CKD. Kidney360. 2020 Apr 13;1(6):436-446. doi: 10.34067/KID.0000062020. eCollection 2020 Jun 25. |
| 31664940 | Derived | Jain N, Wan F, Kothari M, Adelodun A, Ware J, Sarode R, Hedayati SS. Association of platelet function with depression and its treatment with sertraline in patients with chronic kidney disease: analysis of a randomized trial. BMC Nephrol. 2019 Oct 29;20(1):395. doi: 10.1186/s12882-019-1576-7. |
| Placebo |
Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode placebo: Placebo tablet will be identical and matched to sertraline tablet. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Chronic Kidney Disease Stage | Chronic kidney disease stages were categorized as follows: stage 3, estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m^2; stage 4, eGFR of 15-29; and stage 5, eGFR<15, but not dialysis-dependent. | Count of Participants | Participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Estimated glomerular filtration rate | Median | Inter-Quartile Range | mL/min/1.73 m^2 |
|
| 16-item Quick Inventory of Depression Symptomatology Clinician-rated Score | The 16-item Quick Inventory of Depression Symptomatology measures depressive symptom severity. The range of final score is 0-27, with higher scores indicating more severe depression. A score of 0-5 corresponds to normal affect, 6-10 to mild, 11-15 to moderate, 16-20 to severe, and 21 to very severe depression. | Mean | Standard Deviation | units on a scale |
|
Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode placebo: Placebo tablet will be identical and matched to sertraline tablet. |
|
|
|
| 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. | Posted | Number | participants | baseline to 12 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | baseline to 12 weeks |
|
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | baseline to 12 weeks |
|
|
|
|
| Secondary | Serious Adverse Events During the 12 Week Study Duration. | death, dialysis initiation, hospitalizations, or bleeding requiring transfusion | Posted | Count of Participants | Participants | during 12 week study duration |
|
|
|
|
| 0 |
| 97 |
| 13 |
| 97 |
| 55 |
| 97 |
| EG001 | Placebo | Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode placebo: Placebo tablet will be identical and matched to sertraline tablet. | 0 | 96 | 13 | 96 | 35 | 96 |
|
| Hospitalization other than for dialysis initiation | General disorders | Systematic Assessment |
|
| acute suicidal intent | Psychiatric disorders | Systematic Assessment |
|
| Bleeding requiring a blood transfusion or hospitalization | Blood and lymphatic system disorders | Systematic Assessment |
|
| stroke | Nervous system disorders | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| anorexia | Gastrointestinal disorders | Systematic Assessment |
|
| Increased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Somnolence | General disorders | Systematic Assessment |
|
| Decreased memory or confusion | Nervous system disorders | Systematic Assessment |
|
| Dizziness, syncope, or fall | General disorders | Systematic Assessment |
|
| Anxiety, irritability, or agitation | Psychiatric disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Decrease libido or erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
Represents remission outcome. |
| Superiority |
| Hospitalization other than dialysis initiation |
|
| acute suicidal intent |
|
| bleed with transfusion or hospitalization |
|
For comparison of dialysis initiation between groups.
| Superiority |
| Chi-squared | >0.99 | Hospitalization other than dialysis initiation | Superiority |
| Chi-squared | 0.5 | For comparison of acute suicidal intent. | Superiority |
| Chi-squared | >0.99 | For comparison of bleeding requiring blood transfusion or hospitalization. | Superiority |