Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 128 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00976560
The ClinicalTrials.gov registry entry for NCT00976560 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00976560 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.