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NCT00976560 · ClinicalTrials.gov registry record · Phase 2
Clinical Study to Test a New Drug to Treat Major Depression
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
NCT00976560: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00976560 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 128 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00976560, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
Study Summary
In this randomized, double-blind, multi-centre, placebo controlled, exploratory, adaptive design study, the antidepressant and plasma cytokine lowering effects of the GW856553 will be investigated in adult subjects diagnosed with MDD. Subjects will receive oral doses of GW856553 or placebo for six weeks. Safety, tolerability, pharmacokinetics and pharmacodynamics, defined as biomarkers in blood and clinical symptoms, will be assessed. The primary endpoint is the change from baseline associated with GW856553 versus placebo at Week 6 in the Bech (6-item HAMD-17) score. Interim analyses of the primary endpoint will be performed throughout the study to potentially adapt the study design by changing the randomization ratio and/ or reducing the total number of subjects to be randomized into the study. Exploratory analyses will be performed by associating changes in cytokine levels and selected clinical symptoms; PK/PD modelling will also be used to identify the most sensitive clinical and biological markers.
Primary Outcome
HAMD-17 has 17 questions. The HAMD-17 Total Score was calculated by summing the individual response scores over the 17 individual components of the interview. The highest possible score was 52, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. There were 9 five point questions and 8 three point questions. The responses to the individual questions had values of 0-2 (three points response) or 0-4 (five points respo
Interventions
- OTHER Placebo
- DRUG GW856553
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2009-09-25 |
| Est. Completion | 2010-07-07 |
| Phase | Phase 2 |
What the finished NCT00976560 record still lists
NCT00976560 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00976560 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00976560 about?
NCT00976560 is a clinical study titled "Clinical Study to Test a New Drug to Treat Major Depression". In this randomized, double-blind, multi-centre, placebo controlled, exploratory, adaptive design study, the antidepressant and plasma cytokine lowering effects of the GW856553 will be investigated in adult subjects diagnosed with MDD. Subjects will receive oral doses of GW856553 or placebo for six w...
What is the current status of trial NCT00976560?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2009-09-25. Estimated completion is 2010-07-07.
What interventions are being tested in trial NCT00976560?
The interventions under investigation include: Placebo (OTHER), GW856553 (DRUG).
Who is sponsoring clinical trial NCT00976560?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00976560's enrollment target sits among peer trials
128 553rd of 2000 higher than 1,446 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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