Dietary Intervention for Bipolar Disorder
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 8/30/2018 |
| Start Date: | October 2014 |
| End Date: | February 2019 |
Targeted Alterations in n-3 and n‐6 Fatty Acids for the Management of Mood Variability in the Maintenance Phase of 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 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.
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.
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.
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.
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
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