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NCT02272010 · ClinicalTrials.gov registry record · NA
Dietary Intervention for Bipolar Disorder
A NA study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 83
- Enrollment target
NCT02272010: Completed NA study, sponsored by Milton S. Hershey Medical Center.
NCT02272010 is a NA study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 83 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02272010, a NA study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 83 participants
- Enrollment target
Study Summary
Bipolar disorder (BD) is a chronic, often disabling illness, and many individuals remain symptomatic despite pharmacotherapy. Significant mood variability often persists throughout the lifespan and predicts relapse, leading to functional impairment. Metabolism of dietary essential polyunsaturated fatty acids has been shown to be upstream of the neuroinflammatory processes that may lead to neurotoxicity and chronicity of illness in BD. The investigators hypothesize that an intervention diet designed to alter intake of polyunsaturated fatty acids that augments mood stabilizing medications will reduce inflammation; and that the reduction of inflammation will reduce mood variability in bipolar disorder. After a two-the investigatorsek baseline-monitoring period, the investigators will randomize individuals with BD to an intervention or a control diet. Mood will be measured daily using a smartphone. Phase 2 will consist of 12 the investigatorseks of a less intense intervention. Follow-up will then be completed at 6, 9, and 12 months post-baseline to assess for recurrence of mood episodes. By maintaining a certain diet in addition to taking mood-stabilizing medication, researchers hope to see whether specific dietary plans have any bearing on mood variability.
Primary Outcome
Each individual will be given a smartphone for fourteen weeks (2 weeks baseline plus 12 week phase 1 intervention) to measure facets of mood, sleep, and pain.
Interventions
- OTHER Experimental Diet
- OTHER Comparator Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2014-10 |
| Est. Completion | 2019-04 |
| Phase | NA |
What the finished NCT02272010 record still lists
NCT02272010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Experimental Diet is the first listed.
NCT02272010 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02272010 about?
NCT02272010 is a clinical study titled "Dietary Intervention for Bipolar Disorder". Bipolar disorder (BD) is a chronic, often disabling illness, and many individuals remain symptomatic despite pharmacotherapy. Significant mood variability often persists throughout the lifespan and predicts relapse, leading to functional impairment. Metabolism of dietary essential polyunsaturated fa...
What is the current status of trial NCT02272010?
This trial is currently completed. It is a NA study. The enrollment target is 83 participants. The study started on 2014-10. Estimated completion is 2019-04.
What interventions are being tested in trial NCT02272010?
The interventions under investigation include: Experimental Diet (OTHER), Comparator Diet (OTHER).
Who is sponsoring clinical trial NCT02272010?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02272010's enrollment target sits among peer trials
83 990th of 2000 higher than 1,011 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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