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NCT00946998 · ClinicalTrials.gov registry record · Phase 3
Chronic Kidney Disease Antidepressant Sertraline Trial
A Phase 3 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 201
- Enrollment target
NCT00946998: Completed Phase 3 study, sponsored by VA Office of Research and Development.
NCT00946998 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 201 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00946998, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 201 participants
- Enrollment target
Study 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 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.
Primary Outcome
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.
Interventions
- DRUG placebo
- DRUG Sertraline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2010-02-08 |
| Est. Completion | 2017-11 |
| Phase | Phase 3 |
What the finished NCT00946998 record still lists
NCT00946998 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00946998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00946998 about?
NCT00946998 is a clinical study titled "Chronic Kidney Disease Antidepressant Sertraline Trial". 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 in...
What is the current status of trial NCT00946998?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 201 participants. The study started on 2010-02-08. Estimated completion is 2017-11.
What interventions are being tested in trial NCT00946998?
The interventions under investigation include: placebo (DRUG), Sertraline (DRUG).
Who is sponsoring clinical trial NCT00946998?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00946998's enrollment target sits among peer trials
201 1353rd of 2000 higher than 648 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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