Chronic Kidney Disease Antidepressant Sertraline Trial

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-08

Study Completion Date

2017-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Chronic Kidney Disease Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sertraline

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

Group Type ACTIVE_COMPARATOR

Sertraline

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo tablet will be identical and matched to sertraline tablet.

Interventions

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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

Intervention Type DRUG

placebo

Placebo tablet will be identical and matched to sertraline tablet.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No