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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: Completed Phase 2 study, sponsored by University Health Network, Toronto.
NCT02363738 is a Phase 2 study that has completed, run by University Health Network, Toronto. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Baseline and Week 12 Montgomery-Asberg Depression Rating Scale scores are provided, with the range of possible values on the scale from 0 to 60. The higher the score, the worse the overall depressive symptoms.
Interventions
- OTHER Saline
- DRUG Infliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2015-09 |
| Est. Completion | 2017-04 |
| Phase | Phase 2 |
What the finished NCT02363738 record still lists
NCT02363738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT02363738 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02363738's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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