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NCT02415166 · ClinicalTrials.gov registry record · NA
Influenza Challenge in Mood Disorders
A NA study, sponsored by Laureate Institute for Brain Research.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT02415166: Clinical Trial NA study, sponsored by Laureate Institute for Brain Research.
NCT02415166 is a NA study that was terminated before completion, run by Laureate Institute for Brain Research. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02415166, a NA study, was terminated before completion, sponsored by Laureate Institute for Brain Research.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
The aim of this project is to evaluate the efficacy of the influenza vaccine in individuals with major depressive disorder (MDD) as well as to elucidate the nature of the immunological abnormalities in MDD using a quasi-experimental design. Specifically, the investigators plan to induce transient, mild inflammation in medically-healthy study participants using the influenza vaccine. Initially the investigators will conduct a pilot project with up to 20 individuals in order to evaluate the time-point at which the peak inflammatory response to the vaccine occurs. Subjects will receive the seasonal influenza vaccine and provide blood samples 4 hours, 2 days, and 30 days post vaccination. Subsequent to the pilot study, both depressed and psychiatrically-healthy participants will be randomized in a parallel group, double-blind design so that they receive either influenza vaccine (seasonal vaccine) or saline (i.m). At baseline, subjects will provide a blood sample, complete a number of rating scales to measure mood and fatigue, and may complete approximately one hour of MRI scanning with or without simultaneous EEG recording. Two-days post vaccination, they will provide a second blood sample, complete more clinical ratings and may complete another identical MRI session with or without simultaneous EEG. Four weeks later, participants will be asked to return to provide a third blood sample and complete additional clinical ratings. The blood samples will be used to measure both innate and adaptive immune function and may be used to correlate the vaccine-induced immunological changes to neurophysiological changes in the brain measured by MRI and/or EEG.
Primary Outcome
Outcome data were not collected. This was a failed study as all participants, including those who were putatively vaccine-naive had antibodies to influenza at baseline and therefore the original hypothesis could not be tested. The study was terminated.
Interventions
- BIOLOGICAL INFLUENZA VACCINE
- OTHER NaCl-saline placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-03 |
| Phase | NA |
Why NCT02415166 stopped before completion
NCT02415166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which INFLUENZA VACCINE is the first listed.
NCT02415166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02415166 about?
NCT02415166 is a clinical study titled "Influenza Challenge in Mood Disorders". The aim of this project is to evaluate the efficacy of the influenza vaccine in individuals with major depressive disorder (MDD) as well as to elucidate the nature of the immunological abnormalities in MDD using a quasi-experimental design. Specifically, the investigators plan to induce transient, m...
What is the current status of trial NCT02415166?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2015-07. Estimated completion is 2016-03.
What interventions are being tested in trial NCT02415166?
The interventions under investigation include: INFLUENZA VACCINE (BIOLOGICAL), NaCl-saline placebo (OTHER).
Who is sponsoring clinical trial NCT02415166?
This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02415166's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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