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NCT02363738 · ClinicalTrials.gov registry record · Phase 2
12-Week Study Evaluating the Efficacy, Safety, and Tolerability of Adjunctive Infliximab for Bipolar I/II Depression
A Phase 2 study, sponsored by University Health Network, Toronto.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT02363738 is a Phase 2 study that has completed, run by University Health Network, Toronto. The registered enrollment target is 60 participants.
The verdict
NCT02363738, a Phase 2 study, has completed, sponsored by University Health Network, Toronto.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
Studies show the presence of immuno-inflammatory disturbances in individuals with Bipolar Disorders (BD). Increased levels of circulating proteins known as cytokines that promote inflammation have been consistently reported in individuals with bipolar disorders. A particular cytokine referred to as Tumor Necrosis Factor (TNF)-alpha is among those cytokines that have been consistently identified across depressive, manic, and euthymic periods. Disturbances in inflammation however, are not seen in all individual with bipolar disorder. Those individuals with signs of inflammation also often present with higher prevalence of medical disorders that are also associated with inflammation. Those individuals with significant signs of inflammation may respond to anti-inflammatory treatments. In this study, individuals with bipolar depression who exhibit signs of high inflammation will be enrolled and treated with either an anti-inflammatory biologic known as infliximab or placebo (saline).
Interventions
- OTHER Saline
- DRUG Infliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2015-09 |
| Est. Completion | 2017-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02363738
The ClinicalTrials.gov registry entry for NCT02363738 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Health Network, Toronto, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT02363738 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02363738 about?
NCT02363738 is a clinical study titled "12-Week Study Evaluating the Efficacy, Safety, and Tolerability of Adjunctive Infliximab for Bipolar I/II Depression". Studies show the presence of immuno-inflammatory disturbances in individuals with Bipolar Disorders (BD). Increased levels of circulating proteins known as cytokines that promote inflammation have been consistently reported in individuals with bipolar disorders. A particular cytokine referred to as ...
What is the current status of trial NCT02363738?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2015-09. Estimated completion is 2017-04.
What interventions are being tested in trial NCT02363738?
The interventions under investigation include: Saline (OTHER), Infliximab (DRUG).
Who is sponsoring clinical trial NCT02363738?
This trial is sponsored by University Health Network, Toronto, which has 23 total clinical trials registered on ClinicalTrials.gov.
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