Chronic Kidney Disease Antidepressant Sertraline Trial (CAST)

VA Office of Research and Development

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease; Depression

Treatments: Drug: placebo; Drug: Sertraline

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT00946998

1I01CX000217-01 (U.S. NIH Grant/Contract)

1R01DK085512-01A1 (U.S. NIH Grant/Contract)

CLIN-008-09S

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

201 participants in 2 patient groups, including a placebo group

Sertraline

Active Comparator group

Description:

Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode

Treatment:

Drug: Sertraline

Placebo

Placebo Comparator group

Description:

Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode

Treatment:

Drug: placebo