CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 83 enrolled
Drug / intervention
Experimental Diet +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02272010
NCT02272010N/ACompleted

Targeted Alterations in n-3 and n-6 Fatty Acids for the Management of Mood Variability in the Maintenance Phase of Bipolar Disorder

Milton S. Hershey Medical Center·interventional·Posted Oct 22, 2014·Updated May 10, 2019

In Brief

A clinical study evaluating Experimental Diet and Comparator Diet for Bipolar Disorder. Completed, enrolled 83 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 22, 2014
Enrollment StartOct 1, 2014
Primary CompletionApr 1, 2018
Study CompletionApr 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.7 years ago

Interventions

Experimental Dietother

Altered n-6 (linoleic acid) and n-3 (eicosapentaenic acid (EPA) + docosahexaenoic acid (DHA)) diet.

Comparator Dietother

Diet standardized to the usual American distribution of n-6 (7%) and n-3 EPA+DHA (150 mg per day).