Chronic Kidney Disease Antidepressant Sertraline Trial

Depression Clinical Trial

— CAST  

Official title:

Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946998
• Other study ID #: CLIN-008-09S
• Secondary ID: 1I01CX000217-011
• Status: Completed
• Phase: Phase 3
• First received: July 23, 2009
• Last updated: February 9, 2018
• Start date: February 8, 2010
• Est. completion date: November 2017

Study information

• Verified date: February 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: November 2017
• Est. primary completion date: November 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Depression
• Depressive Disorder
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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
Placebo tablet will be identical and matched to sertraline tablet.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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) — View Citation

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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline to 12 weeks
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.	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.	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.	baseline to 12 weeks
Secondary	Serious Adverse Events During the 12 Week Study Duration.	death, dialysis initiation, hospitalizations, or bleeding requiring transfusion	during 12 week study duration