Trial Outcomes & Findings for Chronic Kidney Disease Antidepressant Sertraline Trial (NCT NCT00946998)
NCT ID: NCT00946998
Last Updated: 2018-03-09
Results Overview
The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
201 participants
Primary outcome timeframe
baseline to 12 weeks
Results posted on
2018-03-09
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
99
|
|
Overall Study
Received Treatment as Randomized
|
102
|
99
|
|
Overall Study
COMPLETED
|
97
|
96
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Exited prior to first outcome assessment
|
5
|
3
|
Baseline Characteristics
Chronic Kidney Disease Antidepressant Sertraline Trial
Baseline characteristics by cohort
| Measure |
Sertraline
n=97 Participants
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
n=96 Participants
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
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Estimated glomerular filtration rate
|
27.0 mL/min/1.73 m^2
n=5 Participants
|
27.5 mL/min/1.73 m^2
n=7 Participants
|
27.5 mL/min/1.73 m^2
n=5 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=5 Participants
|
96 participants
n=7 Participants
|
193 participants
n=5 Participants
|
|
Chronic Kidney Disease Stage
CKD Stage 3
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Chronic Kidney Disease Stage
CKD Stage 4
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Chronic Kidney Disease Stage
CKD Stage 5
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Diabetes Mellitus
|
58 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
16-item Quick Inventory of Depression Symptomatology Clinician-rated Score
|
14.0 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
14.1 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
14.0 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
59.1 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
56 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 12 weeksThe score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression.
Outcome measures
| Measure |
Sertraline
n=97 Participants
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
n=96 Participants
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.
|
|---|---|---|
|
Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.
|
-4.1 units on a scale
Interval -5.1 to -3.1
|
-4.2 units on a scale
Interval -5.0 to -3.5
|
SECONDARY outcome
Timeframe: baseline to 12 weeksThe score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression.
Outcome measures
| Measure |
Sertraline
n=97 Participants
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
n=96 Participants
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.
|
|---|---|---|
|
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
Response (>/=50% decline in score)
|
31 participants
|
24 participants
|
|
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
Remission (score =/<5)
|
15 participants
|
14 participants
|
SECONDARY outcome
Timeframe: baseline to 12 weeksEach item is rated on a 0 to 8 Likert scale with 0 indicating no impairment and 8 indicating severe impairment and a total score range of 0 to 40.
Outcome measures
| Measure |
Sertraline
n=97 Participants
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
n=96 Participants
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.
|
|---|---|---|
|
Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale
|
-5.0 units on a scale
Interval -7.6 to -2.5
|
-3.2 units on a scale
Interval -5.8 to -0.7
|
SECONDARY outcome
Timeframe: baseline to 12 weeksRaw scores from version 1.3 were transformed to a scale from 0 to 100, in which higher numbers signify more favorable quality of life.
Outcome measures
| Measure |
Sertraline
n=97 Participants
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
n=96 Participants
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.
|
|---|---|---|
|
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.
|
0.0 units on a scale
Interval -10.0 to 10.0
|
0.0 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: during 12 week study durationdeath, dialysis initiation, hospitalizations, or bleeding requiring transfusion
Outcome measures
| Measure |
Sertraline
n=97 Participants
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
n=96 Participants
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.
|
|---|---|---|
|
Serious Adverse Events During the 12 Week Study Duration.
Death
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events During the 12 Week Study Duration.
Dialysis initiation
|
7 Participants
|
5 Participants
|
|
Serious Adverse Events During the 12 Week Study Duration.
Hospitalization other than dialysis initiation
|
8 Participants
|
7 Participants
|
|
Serious Adverse Events During the 12 Week Study Duration.
acute suicidal intent
|
0 Participants
|
1 Participants
|
|
Serious Adverse Events During the 12 Week Study Duration.
bleed with transfusion or hospitalization
|
2 Participants
|
2 Participants
|
Adverse Events
Sertraline
Serious events: 13 serious events
Other events: 55 other events
Deaths: 0 deaths
Placebo
Serious events: 13 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sertraline
n=97 participants at risk
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
n=96 participants at risk
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.
|
|---|---|---|
|
Renal and urinary disorders
Dialysis initiation
|
7.2%
7/97 • 12 weeks of randomized study duration.
|
5.2%
5/96 • 12 weeks of randomized study duration.
|
|
General disorders
Hospitalization other than for dialysis initiation
|
8.2%
8/97 • 12 weeks of randomized study duration.
|
7.3%
7/96 • 12 weeks of randomized study duration.
|
|
Psychiatric disorders
acute suicidal intent
|
0.00%
0/97 • 12 weeks of randomized study duration.
|
1.0%
1/96 • 12 weeks of randomized study duration.
|
|
Blood and lymphatic system disorders
Bleeding requiring a blood transfusion or hospitalization
|
2.1%
2/97 • 12 weeks of randomized study duration.
|
2.1%
2/96 • 12 weeks of randomized study duration.
|
|
Nervous system disorders
stroke
|
1.0%
1/97 • 12 weeks of randomized study duration.
|
1.0%
1/96 • 12 weeks of randomized study duration.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/97 • 12 weeks of randomized study duration.
|
1.0%
1/96 • 12 weeks of randomized study duration.
|
Other adverse events
| Measure |
Sertraline
n=97 participants at risk
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
n=96 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea, indigestion, or vomiting
|
22.7%
22/97 • 12 weeks of randomized study duration.
|
10.4%
10/96 • 12 weeks of randomized study duration.
|
|
Gastrointestinal disorders
Diarrhea
|
13.4%
13/97 • 12 weeks of randomized study duration.
|
3.1%
3/96 • 12 weeks of randomized study duration.
|
|
Gastrointestinal disorders
anorexia
|
1.0%
1/97 • 12 weeks of randomized study duration.
|
1.0%
1/96 • 12 weeks of randomized study duration.
|
|
Gastrointestinal disorders
Increased appetite
|
1.0%
1/97 • 12 weeks of randomized study duration.
|
2.1%
2/96 • 12 weeks of randomized study duration.
|
|
General disorders
Insomnia
|
7.2%
7/97 • 12 weeks of randomized study duration.
|
10.4%
10/96 • 12 weeks of randomized study duration.
|
|
General disorders
Somnolence
|
9.3%
9/97 • 12 weeks of randomized study duration.
|
5.2%
5/96 • 12 weeks of randomized study duration.
|
|
Nervous system disorders
Decreased memory or confusion
|
2.1%
2/97 • 12 weeks of randomized study duration.
|
3.1%
3/96 • 12 weeks of randomized study duration.
|
|
General disorders
Dizziness, syncope, or fall
|
8.2%
8/97 • 12 weeks of randomized study duration.
|
4.2%
4/96 • 12 weeks of randomized study duration.
|
|
Psychiatric disorders
Anxiety, irritability, or agitation
|
7.2%
7/97 • 12 weeks of randomized study duration.
|
4.2%
4/96 • 12 weeks of randomized study duration.
|
|
Nervous system disorders
Tremor
|
3.1%
3/97 • 12 weeks of randomized study duration.
|
1.0%
1/96 • 12 weeks of randomized study duration.
|
|
General disorders
Headache
|
6.2%
6/97 • 12 weeks of randomized study duration.
|
4.2%
4/96 • 12 weeks of randomized study duration.
|
|
General disorders
Dry mouth
|
4.1%
4/97 • 12 weeks of randomized study duration.
|
4.2%
4/96 • 12 weeks of randomized study duration.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
3/97 • 12 weeks of randomized study duration.
|
1.0%
1/96 • 12 weeks of randomized study duration.
|
|
Reproductive system and breast disorders
Decrease libido or erectile dysfunction
|
3.1%
3/97 • 12 weeks of randomized study duration.
|
2.1%
2/96 • 12 weeks of randomized study duration.
|
Additional Information
Susan Hedayati, MD, Professor of Medicine
University of Texas Southwestern Medical Center
Phone: 214-645-6106
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place