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Chronic Kidney Disease Antidepressant Sertraline Trial (CAST)

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ClinicalTrials.gov Identifier: NCT00946998
Recruitment Status : Completed
First Posted : July 27, 2009
Results First Posted : January 30, 2018
Last Update Posted : March 9, 2018
Sponsor:
Collaborators:
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Chronic Kidney Disease
Depression
Interventions: Drug: Sertraline
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sertraline

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

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

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

placebo: Placebo tablet will be identical and matched to sertraline tablet.


Participant Flow:   Overall Study
    Sertraline   Placebo
STARTED   102   99 
Received Treatment as Randomized   102   99 
COMPLETED   97   96 
NOT COMPLETED   5   3 
Exited prior to first outcome assessment                5                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Sertraline

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

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

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

placebo: Placebo tablet will be identical and matched to sertraline tablet.

Total Total of all reporting groups

Baseline Measures
   Sertraline   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 97   96   193 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.7  (14.5)   59.1  (12.2)   58.4  (13.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23  23.7%      29  30.2%      52  26.9% 
Male      74  76.3%      67  69.8%      141  73.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      21  21.6%      14  14.6%      35  18.1% 
Not Hispanic or Latino      76  78.4%      82  85.4%      158  81.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      1   1.0%      1   0.5% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      56  57.7%      55  57.3%      111  57.5% 
White      41  42.3%      40  41.7%      81  42.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   97   96   193 
Chronic Kidney Disease Stage [1] 
[Units: Participants]
Count of Participants
     
CKD Stage 3      46  47.4%      44  45.8%      90  46.6% 
CKD Stage 4      34  35.1%      36  37.5%      70  36.3% 
CKD Stage 5      17  17.5%      16  16.7%      33  17.1% 
[1] Chronic kidney disease stages were categorized as follows: stage 3, estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m^2; stage 4, eGFR of 15-29; and stage 5, eGFR<15, but not dialysis-dependent.
Diabetes Mellitus 
[Units: Participants]
Count of Participants
 58   55   113 
Estimated glomerular filtration rate 
[Units: mL/min/1.73 m^2]
Median (Inter-Quartile Range)
 27.0 
 (18.0 to 35.0) 
 27.5 
 (17.0 to 38.5) 
 27.5 
 (17.0 to 37.0) 
16-item Quick Inventory of Depression Symptomatology Clinician-rated Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 14.0  (2.4)   14.1  (2.4)   14.0  (2.4) 
[1] The 16-item Quick Inventory of Depression Symptomatology measures depressive symptom severity. The range of final score is 0-27, with higher scores indicating more severe depression. A score of 0-5 corresponds to normal affect, 6-10 to mild, 11-15 to moderate, 16-20 to severe, and 21 to very severe depression.


  Outcome Measures

1.  Primary:   Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.   [ Time Frame: baseline to 12 weeks ]

2.  Secondary:   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 ]

3.  Secondary:   Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale   [ Time Frame: baseline to 12 weeks ]

4.  Secondary:   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 ]

5.  Secondary:   Serious Adverse Events During the 12 Week Study Duration.   [ Time Frame: during 12 week study duration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Susan Hedayati, MD, Professor of Medicine
Organization: University of Texas Southwestern Medical Center
phone: 214-645-6106
e-mail: susan.hedayati@utsouthwestern.edu


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00946998     History of Changes
Other Study ID Numbers: CLIN-008-09S
1I01CX000217-01 ( U.S. NIH Grant/Contract )
1R01DK085512-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 23, 2009
First Posted: July 27, 2009
Results First Submitted: January 12, 2018
Results First Posted: January 30, 2018
Last Update Posted: March 9, 2018