Chronic Kidney Disease Antidepressant Sertraline Trial
Condition: Chronic Kidney Disease; Depression
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Depression; Depressive Disorder
Intervention: Sertraline; placebo
Intervention description: 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 tablet will be identical and matched to sertraline tablet.
Intervention MeSH terms: Sertraline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Depression; Antidepressants; randomized controlled trial; treatment; Sertraline

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.
    

Eligibility 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