Bipolar DisorderNCT02272010
Dietary Intervention for Bipolar Disorder
A study testing Experimental Diet and Comparator Diet in people with Bipolar Disorder, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Experimental Diet and Comparator Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BD - history of at least one manic or mixed episode
- Clinically significant hypomania or depression
- Current psychiatric treatment
- Over 18
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S. Hershey Medical Center Clinical Research Center
Hershey, Pennsylvania, 17033
About this study
Official title: 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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Experimental Diet, Comparator Diet
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental diet | Experimental | Altered n-6 and n-3 fatty acid intake. Receives: Other: Experimental Diet |
| Comparator Diet | Active comparator | Diet standardized to usual n-6 and n-3 intake. Receives: Other: Comparator Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured from the 2-week baseline period to the 12-week period of the phase 1 intervention
Secondary outcomes (1)
Recurrence of mood episode
Recurrence will be measured through phone interviews and review of medical records.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (77)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Responsible party
- Principal investigator, Erika Saunders, Milton S. Hershey Medical Center
- Investigators
- Erika Saunders, M.D, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272010
- Sponsor's protocol ID
- Stanley-13T-013
- Status last verified
- May 2019
- First submitted
- 18 Aug 2014
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Bauer M, Glenn T, Alda M, Grof P, Sagduyu K, Bauer R, Lewitzka U, Whybrow PC. Comparison of pre-episode and pre-remission states using mood ratings from patients with bipolar disorder. Pharmacopsychiatry. 2011 May;44 Suppl 1:S49-53. doi: 10.1055/s-0031-1273765. Epub 2011 May 4.
PubMed 21544745Bauer M, Glenn T, Keil M, Bauer R, Marsh W, Grof P, Alda M, Sagduyu K, Murray G, Quiroz D, Baethge C, Whybrow PC. Brief depressive symptoms in patients with bipolar disorder: analysis of long-term self-reported data. Aust N Z J Psychiatry. 2012 Nov;46(11):1068-78. doi: 10.1177/0004867412452017. Epub 2012 Jun 25.
PubMed 22734088Bauer J, Gottfries GG, Forstl H. Critical comments on "Propionibacterium acnes in the cortex of patients with Alzheimer's disease" by H.H. Kornhuber (Eur Arch Psychiatry Clin Neurosci, 1996, 246:108-109). Eur Arch Psychiatry Clin Neurosci. 1996;246(4):224-6. doi: 10.1007/BF02188958. No abstract available.
PubMed 8832202aan het Rot M, Hogenelst K, Schoevers RA. Mood disorders in everyday life: a systematic review of experience sampling and ecological momentary assessment studies. Clin Psychol Rev. 2012 Aug;32(6):510-23. doi: 10.1016/j.cpr.2012.05.007. Epub 2012 Jun 6.
PubMed 22721999Jen A, Saunders EF, Ornstein RM, Kamali M, McInnis MG. Impulsivity, anxiety, and alcohol misuse in bipolar disorder comorbid with eating disorders. Int J Bipolar Disord. 2013 Aug 6;1:13. doi: 10.1186/2194-7511-1-13. eCollection 2013.
PubMed 25505680Bauer M, Glenn T, Whybrow PC, Grof P, Rasgon N, Alda M, Marsh W, Sagduyu K, Schmid R, Adli M. Changes in self-reported sleep duration predict mood changes in bipolar disorder. Psychol Med. 2008 Jul;38(7):1069-71. doi: 10.1017/S0033291708003280. Epub 2008 Apr 1. No abstract available.
PubMed 18377675Bauer M, Glenn T, Grof P, Pfennig A, Rasgon NL, Marsh W, Munoz RA, Sagduyu K, Alda M, Quiroz D, Sasse J, Whybrow PC. Self-reported data from patients with bipolar disorder: frequency of brief depression. J Affect Disord. 2007 Aug;101(1-3):227-33. doi: 10.1016/j.jad.2006.11.021. Epub 2007 Jan 16.
PubMed 17224186Myin-Germeys I, Oorschot M, Collip D, Lataster J, Delespaul P, van Os J. Experience sampling research in psychopathology: opening the black box of daily life. Psychol Med. 2009 Sep;39(9):1533-47. doi: 10.1017/S0033291708004947. Epub 2009 Feb 12.
PubMed 19215626Myin-Germeys I, Peeters F, Havermans R, Nicolson NA, DeVries MW, Delespaul P, Van Os J. Emotional reactivity to daily life stress in psychosis and affective disorder: an experience sampling study. Acta Psychiatr Scand. 2003 Feb;107(2):124-31. doi: 10.1034/j.1600-0447.2003.02025.x.
PubMed 12534438Keller MB, Lavori PW, Friedman B, Nielsen E, Endicott J, McDonald-Scott P, Andreasen NC. The Longitudinal Interval Follow-up Evaluation. A comprehensive method for assessing outcome in prospective longitudinal studies. Arch Gen Psychiatry. 1987 Jun;44(6):540-8. doi: 10.1001/archpsyc.1987.01800180050009.
PubMed 3579500Ramsden CE, Faurot KR, Zamora D, Suchindran CM, MacIntosh BA, Gaylord S, Ringel A, Hibbeln JR, Feldstein AE, Mori TA, Barden A, Lynch C, Coble R, Mas E, Palsson O, Barrow DA, Mann DJ. Targeted alteration of dietary n-3 and n-6 fatty acids for the treatment of chronic headaches: a randomized trial. Pain. 2013 Nov;154(11):2441-2451. doi: 10.1016/j.pain.2013.07.028. Epub 2013 Jul 22.
PubMed 23886520Merikangas KR, Akiskal HS, Angst J, Greenberg PE, Hirschfeld RM, Petukhova M, Kessler RC. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey replication. Arch Gen Psychiatry. 2007 May;64(5):543-52. doi: 10.1001/archpsyc.64.5.543.
PubMed 17485606Who. The World Health Report: 2001: Mental health: new understanding, new hope. Geneva: World Health Organization; 2001.
Judd LL, Akiskal HS, Schettler PJ, Endicott J, Leon AC, Solomon DA, Coryell W, Maser JD, Keller MB. Psychosocial disability in the course of bipolar I and II disorders: a prospective, comparative, longitudinal study. Arch Gen Psychiatry. 2005 Dec;62(12):1322-30. doi: 10.1001/archpsyc.62.12.1322.
PubMed 16330720Judd LL, Akiskal HS, Schettler PJ, Endicott J, Maser J, Solomon DA, Leon AC, Rice JA, Keller MB. The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry. 2002 Jun;59(6):530-7. doi: 10.1001/archpsyc.59.6.530.
PubMed 12044195
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Alterations in n-3 and n-6 Fatty Acids for the Management of Mood Variability in the Maintenance Phase of Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02272010
- Acronym / sponsor ID
- Stanley-13T-013
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Oct 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental diet | Experimental | Other: Experimental DietAltered n-6 and n-3 fatty acid intake. |
| Comparator Diet | Active comparator | Other: Comparator DietDiet standardized to usual n-6 and n-3 intake. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BD - history of at least one manic or mixed episode
- Clinically significant hypomania or depression
- Current psychiatric treatment
- Over 18
Key exclusion criteria (8 listed)
- Current hospitalization for BD
- Active substance dependence or eating disorder
- Active suicidal/homicidal ideation
- Pregnancy
- Active treatment for major medical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental DietAltered n-6 (linoleic acid) and n-3 (eicosapentaenic acid (EPA) + docosahexaenoic acid (DHA)) diet. | Other | Experimental diet |
| Comparator DietDiet standardized to the usual American distribution of n-6 (7%) and n-3 EPA+DHA (150 mg per day). | Other | Comparator Diet |
Primary outcome
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.
1 secondary outcome
Recurrence of mood episode
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Background: PubMed 21544745Bauer M, Glenn T, Alda M, Grof P, Sagduyu K, Bauer R, Lewitzka U, Whybrow PC. Comparison of pre-episode and pre-remission states using mood ratings from patients with bipolar disorder. Pharmacopsychiatry. 2011 May;44 Suppl 1:S49-53. doi: 10.1055/s-0031-1273765. Epub 2011 May 4.
- Background: PubMed 22734088Bauer M, Glenn T, Keil M, Bauer R, Marsh W, Grof P, Alda M, Sagduyu K, Murray G, Quiroz D, Baethge C, Whybrow PC. Brief depressive symptoms in patients with bipolar disorder: analysis of long-term self-reported data. Aust N Z J Psychiatry. 2012 Nov;46(11):1068-78. doi: 10.1177/0004867412452017. Epub 2012 Jun 25.
- Background: PubMed 8832202Bauer J, Gottfries GG, Forstl H. Critical comments on "Propionibacterium acnes in the cortex of patients with Alzheimer's disease" by H.H. Kornhuber (Eur Arch Psychiatry Clin Neurosci, 1996, 246:108-109). Eur Arch Psychiatry Clin Neurosci. 1996;246(4):224-6. doi: 10.1007/BF02188958. No abstract available.
- Background: PubMed 22721999aan het Rot M, Hogenelst K, Schoevers RA. Mood disorders in everyday life: a systematic review of experience sampling and ecological momentary assessment studies. Clin Psychol Rev. 2012 Aug;32(6):510-23. doi: 10.1016/j.cpr.2012.05.007. Epub 2012 Jun 6.
- Background: PubMed 25505680Jen A, Saunders EF, Ornstein RM, Kamali M, McInnis MG. Impulsivity, anxiety, and alcohol misuse in bipolar disorder comorbid with eating disorders. Int J Bipolar Disord. 2013 Aug 6;1:13. doi: 10.1186/2194-7511-1-13. eCollection 2013.
- Background: PubMed 18377675Bauer M, Glenn T, Whybrow PC, Grof P, Rasgon N, Alda M, Marsh W, Sagduyu K, Schmid R, Adli M. Changes in self-reported sleep duration predict mood changes in bipolar disorder. Psychol Med. 2008 Jul;38(7):1069-71. doi: 10.1017/S0033291708003280. Epub 2008 Apr 1. No abstract available.
- Background: PubMed 17224186Bauer M, Glenn T, Grof P, Pfennig A, Rasgon NL, Marsh W, Munoz RA, Sagduyu K, Alda M, Quiroz D, Sasse J, Whybrow PC. Self-reported data from patients with bipolar disorder: frequency of brief depression. J Affect Disord. 2007 Aug;101(1-3):227-33. doi: 10.1016/j.jad.2006.11.021. Epub 2007 Jan 16.
- Background: PubMed 19215626Myin-Germeys I, Oorschot M, Collip D, Lataster J, Delespaul P, van Os J. Experience sampling research in psychopathology: opening the black box of daily life. Psychol Med. 2009 Sep;39(9):1533-47. doi: 10.1017/S0033291708004947. Epub 2009 Feb 12.
- Background: PubMed 12534438Myin-Germeys I, Peeters F, Havermans R, Nicolson NA, DeVries MW, Delespaul P, Van Os J. Emotional reactivity to daily life stress in psychosis and affective disorder: an experience sampling study. Acta Psychiatr Scand. 2003 Feb;107(2):124-31. doi: 10.1034/j.1600-0447.2003.02025.x.
- Background: PubMed 3579500Keller MB, Lavori PW, Friedman B, Nielsen E, Endicott J, McDonald-Scott P, Andreasen NC. The Longitudinal Interval Follow-up Evaluation. A comprehensive method for assessing outcome in prospective longitudinal studies. Arch Gen Psychiatry. 1987 Jun;44(6):540-8. doi: 10.1001/archpsyc.1987.01800180050009.
- Background: PubMed 23886520Ramsden CE, Faurot KR, Zamora D, Suchindran CM, MacIntosh BA, Gaylord S, Ringel A, Hibbeln JR, Feldstein AE, Mori TA, Barden A, Lynch C, Coble R, Mas E, Palsson O, Barrow DA, Mann DJ. Targeted alteration of dietary n-3 and n-6 fatty acids for the treatment of chronic headaches: a randomized trial. Pain. 2013 Nov;154(11):2441-2451. doi: 10.1016/j.pain.2013.07.028. Epub 2013 Jul 22.
- Background: PubMed 17485606Merikangas KR, Akiskal HS, Angst J, Greenberg PE, Hirschfeld RM, Petukhova M, Kessler RC. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey replication. Arch Gen Psychiatry. 2007 May;64(5):543-52. doi: 10.1001/archpsyc.64.5.543.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Saunders, M.D principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Diet and Comparator Diet in people with Bipolar Disorder, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood variability outcome (time frame: Measured from the 2-week baseline period to the 12-week period of the phase 1 intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02272010, which also lists 77 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.