Chronic Kidney Disease Antidepressant Sertraline Trial - Full Text View

Sponsor:	Department of Veterans Affairs
Collaborator:	University of Texas Southwestern Medical Center
Information provided by (Responsible Party):	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00946998

Purpose

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.

Condition	Intervention
Chronic Kidney Disease Depression	Drug: Sertraline Drug: placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression Kidney Failure

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Improvement in depression symptom severity as measured by the QIDS-C-16 score. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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: 12 weeks ] [ Designated as safety issue: No ]
Improvement in overall function as assessed by the Work and Social Adjustment Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Improvement in quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Serious adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Reduction in platelet aggregation and activation in sertraline vs. placebo group, and whether this reduction correlates with higher plasma sertraline levels. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Determine if sertraline treatment vs. placebo will improve: a. nutritional status; b. adherence to prescribed medications; c. cognitive functioning; and d. markers of inflammation. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2010
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode	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 Comparator: 2 Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode	Drug: placebo Placebo tablet will be identical and matched to sertraline tablet.

Detailed 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946998

Contacts

Contact: Susan Hedayati, MD MHS	(214) 857-2214	susan.hedayati@va.gov
Contact: Mieshia T Beamon	(214) 857-1906	Mieshia.Beamon@va.gov

Locations

United States, Texas
VA North Texas Health Care System, Dallas	Recruiting
Dallas, Texas, United States, 75216
Contact: Debbie A Lindquist, BS 214-857-0238 debbie.lindquist@va.gov
Contact: Julie R Propes (214) 857-0240 Julie.Propes@va.gov
Principal Investigator: Susan Hedayati, MD MHS
University of Texas Southwestern Medical Center at Dallas	Recruiting
Dallas, Texas, United States, 75390
Contact: Kyle West, MA 214-645-8290 Kyle.West@UTSouthwestern.edu

Sponsors and Collaborators

Department of Veterans Affairs

University of Texas Southwestern Medical Center

Investigators

Principal Investigator:

Susan Hedayati, MD MHS

VA North Texas Health Care System, Dallas

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00946998 History of Changes
Other Study ID Numbers:	CLIN-008-09S, 1I01CX000217-01, 1R01DK085512-01A1
Study First Received:	July 23, 2009
Last Updated:	December 1, 2011
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Chronic Kidney Disease
Depression
Antidepressants

randomized controlled trial
treatment
Sertraline

Additional relevant MeSH terms:

Depression
Depressive Disorder
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Urologic Diseases
Renal Insufficiency
Antidepressive Agents

Sertraline
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012