Trial · NCT00946998

Chronic Kidney Disease Antidepressant Sertraline Trial

NCT00946998, Phase 3, Completed, VA Office of Research and Development; results first posted 2018-01-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Chronic Kidney Disease Antidepressant Sertraline Trial. Trials, record NCT00946998. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00946998

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Chronic Kidney Disease Antidepressant Sertraline Trial
NCT number: NCT00946998
Status: Completed
Phases: Phase 3
Enrollment: 201 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Chronic Kidney Disease, Depression
Interventions: Sertraline, placebo
First posted: 2009-07-27
Last updated: 2018-03-09
Results first posted: 2018-01-30

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.	baseline to 12 weeks	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.
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	baseline to 12 weeks	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.
Secondary	Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale	baseline to 12 weeks	Each 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.
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.	baseline to 12 weeks	Raw scores from version 1.3 were transformed to a scale from 0 to 100, in which higher numbers signify more favorable quality of life.
Secondary	Serious Adverse Events During the 12 Week Study Duration.	during 12 week study duration	death, dialysis initiation, hospitalizations, or bleeding requiring transfusion

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.	baseline to 12 weeks	units on a scale	MEAN
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	baseline to 12 weeks	participants	NUMBER
SECONDARY	Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale	baseline to 12 weeks	units on a scale	MEAN
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.	baseline to 12 weeks	units on a scale	MEDIAN
SECONDARY	Serious Adverse Events During the 12 Week Study Duration.	during 12 week study duration	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.	Sertraline		-4.1	95% Confidence Interval -5.1 to -3.1	units on a scale
Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.	Placebo		-4.2	95% Confidence Interval -5.0 to -3.5	units on a scale
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	Sertraline	Response (>/=50% decline in score)	31		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	Placebo	Response (>/=50% decline in score)	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	Sertraline	Remission (score =/<5)	15		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	Placebo	Remission (score =/<5)	14		participants
Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale	Sertraline		-5.0	95% Confidence Interval -7.6 to -2.5	units on a scale
Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale	Placebo		-3.2	95% Confidence Interval -5.8 to -0.7	units on a scale
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.	Sertraline		0.0	Inter-Quartile Range -10.0 to 10.0	units on a scale
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.	Placebo		0.0	Inter-Quartile Range 0.0 to 10.0	units on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sertraline	102
Overall Study	STARTED	Placebo	99
Overall Study	Received Treatment as Randomized	Sertraline	102
Overall Study	Received Treatment as Randomized	Placebo	99
Overall Study	COMPLETED	Sertraline	97
Overall Study	COMPLETED	Placebo	96
Overall Study	NOT COMPLETED	Sertraline	5
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea, indigestion, or vomiting	Gastrointestinal disorders	Sertraline	22	97
other	Nausea, indigestion, or vomiting	Gastrointestinal disorders	Placebo	10	96
other	Diarrhea	Gastrointestinal disorders	Sertraline	13	97
other	Diarrhea	Gastrointestinal disorders	Placebo	3	96
other	anorexia	Gastrointestinal disorders	Sertraline	1	97
other	anorexia	Gastrointestinal disorders	Placebo	1	96
other	Increased appetite	Gastrointestinal disorders	Sertraline	1	97
other	Increased appetite	Gastrointestinal disorders	Placebo	2	96
other	Insomnia	General disorders	Sertraline	7	97
other	Insomnia	General disorders	Placebo	10	96

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sertraline	0	97
Total, all-cause mortality	Placebo	0	96
Total, other adverse events	Sertraline	55	97
Total, other adverse events	Placebo	35	96
Total, serious adverse events	Sertraline	13	97
Total, serious adverse events	Placebo	13	96

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23085503	RESULT	PubMed
29101402	RESULT	PubMed
31664940	DERIVED	PubMed
35368605	DERIVED	PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
R01DK085512	Randomized trial of sertraline treatment of depression in Chronic Kidney Disease	HEDAYATI, SUSAN	UT SOUTHWESTERN MEDICAL CENTER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2011 to 2015	NIH RePORTER
I01CX000217	Randomized trial of sertraline treatment of depression in Chronic Kidney Disease	HEDAYATI, SUSAN	VA NORTH TEXAS HEALTH CARE SYSTEM	Veterans Affairs	2009 to 2012	NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Sertraline vs Placebo: deaths from any cause	Trial comparisons
Sertraline vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00946998

GET https://conductscience.org/api/trials/v1/NCT00946998/events?page=2

API reference For AI assistants