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Dietary Intervention for Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT02272010
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Erika Saunders, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE August 18, 2014
First Posted Date  ICMJE October 22, 2014
Last Update Posted Date May 10, 2019
Study Start Date  ICMJE October 2014
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
Mood variability outcome [ Time Frame: Measured from the 2-week baseline period to the 12-week period of the phase 1 intervention ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
Recurrence of mood episode [ Time Frame: 1 year ]
Recurrence will be measured through phone interviews and review of medical records.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 20, 2014)
  • Plasma levels of omega-6 fatty acids [ Time Frame: Comparing from baseline to weeks 4, 8, 12 ]
    Group comparison of mean change from baseline in plasma levels of fatty acids, metabolites and lipidomics will be measured and analyzed in an exploratory fashion.
  • Psychological distress and general functioning [ Time Frame: Baseline & weeks 0, 4, 8, 12 ]
    Measured by PROMIS-29
  • Mood symptoms [ Time Frame: Baseline & weeks 0, 4, 8, 12, 24, 48 ]
    Mood, sleep, psychosocial stress and pain questionnaires.
  • Plasma levels of omega-3 fatty acids [ Time Frame: Baseline & weeks 4, 8, 12 ]
    Group comparison of mean change from baseline in plasma levels of fatty acids, metabolites and lipidomics will be measured and analyzed in an exploratory fashion.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Dietary Intervention for Bipolar Disorder
Official Title  ICMJE Targeted Alterations in n-3 and n‐6 Fatty Acids for the Management of Mood Variability in the Maintenance Phase of Bipolar Disorder
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.
Detailed Description

The investigators will conduct a 2-arm, parallel group, randomized, controlled 24-week dietary intervention to evaluate the therapeutic efficacy of two dietary interventions in patients with BD. After a two-week baseline-monitoring period, the investigators will randomize 84 patients with chronic BD to augment usual treatment with either an experimentally-altered omega-3, omega-6 intervention or a control diet with average US intakes of n-3 and n-6 fatty acids. Subjects in both groups will remain under the care of their physician for the full duration of the trial. During the first phase of the trial (12 weeks), the intervention will be intense, during the second phase (12 weeks), a less intense intervention will be delivered, and after the two phases of intervention there will be a 24-week follow-up period.

The study is designed to achieve the following specific aims and obtain support for the following hypotheses:

Specific Aim 1 (primary mood outcome): To compare the efficacy of the experimental dietary intervention to the control diet in reducing variability of mood symptoms and reducing general psychological distress.

Hypothesis 1: Compared to the control diet, the experimental intervention will produce significant improvement in (1a) variability of daily mood symptoms, energy, and impulsivity using a Visual Analogue Scale measured using ecological momentary analysis (1); and (1b) psychological distress and general functioning using the PROMIS-29.

Specific Aim 2 (secondary mood outcome): To compare the efficacy of the experimental dietary intervention to the control diet in reducing recurrence.

Hypothesis 2: Compared to the control diet, the experimental intervention will produce significant reduction in recurrence of mood episodes over a 12-month period. To adequately power this study for measurement of recurrence, the investigators would need a sample size 2-3 times what the investigators estimate for this study, therefore the primary mood outcome is not recurrence of episode, but is measurement of mood variability, which in turn predicts recurrence. The investigators will measure recurrence to gather data for future studies.

Specific Aim 3 (primary biochemical outcome): To evaluate whether the experimental dietary intervention can alter n-6 AA and its bioactive metabolites, n-3 DHA and its bioactive metabolites in patients with BD.

Hypothesis 3: Compared to the control diet, the experimental intervention will significantly (1a) alter n-6 AA and n-3 DHA in erythrocytes; and (1b) alter 17-hydroxy DHA and reduce PGE2 in plasma.

Exploratory Aims: In an exploratory manner, the investigators will also (1) compare the efficacy of the experimental dietary intervention to the control diet in improving headache-related clinical endpoints in the subset of BP patients with comorbid migraines; (2) test the effects of the dietary interventions on a wide array of bioactive derivatives of n-3 and n-6 fatty acids and other inflammatory mediators (e.g. cytokines, CRP); and (3) evaluate whether biochemical alterations in n-3 DHA, n-6 AA and their bioactive metabolites are related to clinical improvements (4) compare the efficacy of the experimental dietary intervention to the control diet in preventing recurrence of illness in follow-up; (5) store samples for exploratory biomarker analysis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • Other: Experimental Diet
    Altered n-6 (linoleic acid) and n-3 (eicosapentaenic acid (EPA) + docosahexaenoic acid (DHA)) diet.
  • Other: Comparator Diet
    Diet standardized to the usual American distribution of n-6 (7%) and n-3 EPA+DHA (150 mg per day).
Study Arms  ICMJE
  • Experimental: Experimental diet
    Altered n-6 and n-3 fatty acid intake.
    Intervention: Other: Experimental Diet
  • Active Comparator: Comparator Diet
    Diet standardized to usual n-6 and n-3 intake.
    Intervention: Other: Comparator Diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2018)
83
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2014)
84
Actual Study Completion Date  ICMJE April 2019
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. BD - history of at least one manic or mixed episode
  2. Clinically significant hypomania or depression
  3. Current psychiatric treatment
  4. Over 18

Exclusion Criteria:

  1. Current hospitalization for BD
  2. Active substance dependence or eating disorder
  3. Active suicidal/homicidal ideation
  4. Pregnancy
  5. Active treatment for major medical illness
  6. History of specific food allergies such as, but not limited to, fish, gluten, dairy products
  7. Strong aversion to fish
  8. Any condition or attitude which, in the opinion of the PI, would prevent full cooperation and commitment to the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02272010
Other Study ID Numbers  ICMJE Stanley-13T-013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erika Saunders, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Stanley Medical Research Institute
Investigators  ICMJE
Principal Investigator: Erika Saunders, M.D Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP