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NCT Number: NCT00946998

Chronic Kidney Disease Antidepressant Sertraline Trial

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.

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Key information

Conditions

Chronic Kidney Disease Behavior Behavioral Symptoms Chronic Disease Depression Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo

Drug

Placebo tablet will be identical and matched to sertraline tablet.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Serious Adverse Events During the 12 Week Study Duration.

    Time frame: during 12 week study duration

    death, dialysis initiation, hospitalizations, or bleeding requiring transfusion

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Texas Southwestern Medical Center

Registry information

Official study title

Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease

Acronym: CAST

Important dates

Study start
2010
Primary completion
2016
Study completion
2017
First posted
Jul 27, 2009
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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