Dietary Intervention for Bipolar Disorder

NCT02272010 | Completed

• 1 other identifier: Stanley-13T-013
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Mood variability 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.

  Measured from the 2-week baseline period to the 12-week period of the phase 1 intervention

Secondary Outcomes (1)

• Recurrence of mood episode

  1 year

Other Outcomes (4)

• Plasma levels of omega-6 fatty acids

  Comparing from baseline to weeks 4, 8, 12

• Psychological distress and general functioning

  Baseline & weeks 0, 4, 8, 12

• Mood symptoms

  Baseline & weeks 0, 4, 8, 12, 24, 48

Study Arms (2)

Experimental diet

EXPERIMENTAL

Altered n-6 and n-3 fatty acid intake.

Other: Experimental Diet

Comparator Diet

ACTIVE COMPARATOR

Diet standardized to usual n-6 and n-3 intake.

Other: Comparator Diet

Interventions

Experimental Diet OTHER

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

Experimental diet

Comparator Diet OTHER

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

Comparator Diet

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Milton S. Hershey Medical Center Clinical Research Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (77)

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• Huesch MD, Mukherjee D, Saunders EF. E-recruitment into a bipolar disorder trial using Facebook tailored advertising. Clin Trials. 2018 Oct;15(5):522-523. doi: 10.1177/1740774518784018. Epub 2018 Jun 28. No abstract available.

  PMID: 29952243 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Erika Saunders, M.D

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: October 22, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2019
• Last Updated: May 10, 2019

Record last verified: 2019-05

Locations

US (1)