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Chronic Kidney Disease Antidepressant Sertraline Trial (CAST)
This study is ongoing, but not recruiting participants.
Sponsor:
VA Office of Research and Development
Collaborators:
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00946998
First received: July 23, 2009
Last updated: September 11, 2017
Last verified: September 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Chronic Kidney Disease Depression | Drug: Sertraline Drug: placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease |
Resource links provided by NLM:
Further study details as provided by VA Office of Research and Development:
Primary Outcome Measures:
- Improvement in depression symptom severity as measured by the QIDS-C-16 score. [ Time Frame: 12 weeks ]
Secondary Outcome Measures:
- 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 [ Time Frame: 12 weeks ]
- Improvement in overall function as assessed by the Work and Social Adjustment Scale [ Time Frame: 12 weeks ]
- Improvement in quality of life [ Time Frame: 12 weeks ]
- Serious adverse events [ Time Frame: 12 weeks ]
- Reduction in platelet aggregation and activation in sertraline vs. placebo group, and whether this reduction correlates with higher plasma sertraline levels. [ Time Frame: 12 weeks ]
- Determine if sertraline treatment vs. placebo will improve: a. nutritional status; b. adherence to prescribed medications; c. cognitive functioning; and d. markers of inflammation. [ Time Frame: 12 weeks ]
| Estimated Enrollment: | 200 |
| Actual Study Start Date: | February 8, 2010 |
| Estimated Study Completion Date: | November 2018 |
| Primary Completion Date: | November 23, 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
|
Drug: 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
|
|
Placebo Comparator: Arm 2
Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
|
Drug: placebo
Placebo tablet will be identical and matched to sertraline tablet.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946998
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946998
Locations
| United States, Texas | |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | |
| Dallas, Texas, United States, 75216 | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75390 | |
Sponsors and Collaborators
VA Office of Research and Development
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
| Principal Investigator: | Susan S Hedayati, MD MHS | University of Texas Southwestern Medical Center |
More Information
Publications:
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT00946998 History of Changes |
| Other Study ID Numbers: |
CLIN-008-09S 1I01CX000217-01 ( U.S. NIH Grant/Contract ) 1R01DK085512-01A1 ( U.S. NIH Grant/Contract ) |
| Study First Received: | July 23, 2009 |
| Last Updated: | September 11, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Keywords provided by VA Office of Research and Development:
|
Chronic Kidney Disease Depression Antidepressants |
randomized controlled trial treatment Sertraline |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Kidney Diseases Renal Insufficiency, Chronic Behavioral Symptoms Mood Disorders Mental Disorders Urologic Diseases Renal Insufficiency Antidepressive Agents |
Sertraline Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 19, 2017