Dietary Intervention for Bipolar Disorder

Completed · Not applicable

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT02272010

Run by

Milton S. Hershey Medical Center

People needed

83

Starts

2014-10-01

Expected to finish

2019-04-01

Last updated by the study team

2019-05-10

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BD - history of at least one manic or mixed episode
• Clinically significant hypomania or depression
• Current psychiatric treatment
• Over 18

You may not qualify if…

• Current hospitalization for BD
• Active substance dependence or eating disorder
• Active suicidal/homicidal ideation
• Pregnancy
• Active treatment for major medical illness
• History of specific food allergies such as, but not limited to, fish, gluten, dairy products
• Strong aversion to fish
• Any condition or attitude which, in the opinion of the PI, would prevent full cooperation and commitment to the study

Where it is running

• Milton S. Hershey Medical Center Clinical Research Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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