Chronic Kidney Disease Antidepressant Sertraline Trial (CAST)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00946998 |
Recruitment Status :
Completed
First Posted : July 27, 2009
Results First Posted : January 30, 2018
Last Update Posted : March 9, 2018
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Condition or disease | Intervention/treatment | Phase |
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Chronic Kidney Disease Depression | Drug: Sertraline Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 201 participants |
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 |
Actual Study Start Date : | February 8, 2010 |
Actual Primary Completion Date : | November 23, 2016 |
Actual Study Completion Date : | November 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Sertraline
Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
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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: Placebo
Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
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Drug: placebo
Placebo tablet will be identical and matched to sertraline tablet. |
- Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score. [ Time Frame: baseline to 12 weeks ]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.
- 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: baseline to 12 weeks ]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.
- Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale [ Time Frame: baseline to 12 weeks ]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.
- 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. [ Time Frame: baseline to 12 weeks ]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.
- Serious Adverse Events During the 12 Week Study Duration. [ Time Frame: during 12 week study duration ]death, dialysis initiation, hospitalizations, or bleeding requiring transfusion

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, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946998
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 |
Principal Investigator: | Susan S Hedayati, MD MHS | University of Texas Southwestern Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT00946998 |
Other Study ID Numbers: |
CLIN-008-09S 1I01CX000217-01 ( U.S. NIH Grant/Contract ) 1R01DK085512-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | July 27, 2009 Key Record Dates |
Results First Posted: | January 30, 2018 |
Last Update Posted: | March 9, 2018 |
Last Verified: | February 2018 |
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 |
Chronic Kidney Disease Depression Antidepressants |
randomized controlled trial treatment Sertraline |
Kidney Diseases Renal Insufficiency, Chronic Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Urologic Diseases Renal Insufficiency Sertraline |
Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs |