Status:
COMPLETED
Chronic Kidney Disease Antidepressant Sertraline Trial
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Chronic Kidney Disease
Depression
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief 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 disea...
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 fa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 8 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT00946998
Start Date
February 8 2010
End Date
November 1 2017
Last Update
March 9 2018
Active Locations (2)
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1
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216
2
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390