Bipolar DisorderPhase 2NCT00010868
Omega-3 Fatty Acids in Bipolar Disorder
A Phase 2 study testing Omega-3 Fatty Acids in people with Bipolar Disorder, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites in United States.
Trial summary
This is a 12 month study of omega-3 fatty acids in bipolar disorder. This study will be a 12-month, parallel group, double-blind comparison of the prophylactic efficacy of omega-3 fatty acids vs. placebo in 120 bipolar I patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Omega-3 Fatty Acids
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Jul 2000to Jul 2004
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet DSM-IV criteria for bipolar disorder, type I.
- Have had an episode of mania, hypomania, mixed mania, or major depression within the preceding 12 months, as defined by SCID criteria.
- Able to give informed consent.
Who cannot join
- Patients with significant medical co-morbidity, such as active hepatic or renal disease, any type of coagulopathy, lipidoses, dementia, history of significant head injury, active cancer or cancer treatment, or other medical problems which may interfere with the absorption and metabolism of omega-3 fatty acids. In addition, any medical disorder with symptoms (e.g. aphasia, encephalopathy, etc.) which would make it difficult to determine the clinical response to the study drugs.
- Patients with significant psychiatric co-morbidity, such as another currently active Axis 1 or 2 disorder requiring treatment. Patients with other, active mental disorders may have psychiatric symptoms that would make it difficult to assess mood response to the study drugs. For example, a patient with significant anxiety or panic symptoms requiring medication would be excluded, whereas a patient with past or currently very mild anxiety symptoms not requiring active treatment would be eligible.
- Patients receiving Coumadin, or other drugs with strong effects on coagulation will be excluded due to the theoretical increased risk of bleeding on omega-3 fatty acid therapy. Low dose or intermittent NSAIDs will be permitted.
- Patients receiving drugs which affect lipid metabolism, such as HMG CoA inhibitors, high-dose niacin, gemfibrozil, and others.
- Pregnant patients - due to the unknown effects of high dose omega-3 fatty acids on the fetus.
- Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk, or patients who will not likely be able to comply with the study protocol.
- Bipolar patients receiving clozapine. These patients will be excluded due to the likelihood of extreme treatment resistance in clozapine-treated bipolar disorder. It may be unwise to discontinue the patient's clozapine, since recurrence may occur. Also, based on uncontrolled data, clozapine may be a uniquely effective mood stabilizer, which would add a potential confound to the study.
- Patients who meet DSM-IV criteria for substance abuse within 1 month of this trial or substance dependence within 3 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McLean Hospital
Belmont, Massachusetts, 02478
Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: Omega-3 Fatty Acids in Bipolar Disorder Prophylaxis
This is a 12 month study of omega-3 fatty acids in bipolar disorder. This study will be a 12-month, parallel group, double-blind comparison of the prophylactic efficacy of omega-3 fatty acids vs. placebo in 120 bipolar I patients. All subjects entering the primary prophylactic study will be euthymic or have only subsyndromal mood symptoms for at least 4 weeks. In addition, their concomitant medication (only lithium, divalproex, or no medication will be permitted) will also be stable and at accepted therapeutic levels for at least 4 weeks. An 8-week lead-in phase will be available to subjects who do not meet the current symptom and concomitant medication inclusion criteria (however, subjects must meet all of the other inclusion/exclusion criteria): 1. 4 weeks of euthymic or subsyndromal mood. 2. Subjects who are not already receiving lithium or divalproex. 3. Subjects receiving other psychotropic medications.
- Conditions
- Bipolar Disorder
- Being tested
- Omega-3 Fatty Acids
- Keywords
- bipolar disorder, omega-3 fatty acids, eicosapentaenoic acid, docosahexaenoic acid
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2001 (estimated)
- Study startJul 2000
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Pronova BioPharma
- Investigators
- Andrew L. Stoll, M.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010868
- Sponsor's protocol ID
- R01AT000161-02
- Status last verified
- Jul 2006
- First submitted
- 2 Feb 2001
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
Stoll AL, Severus WE, Freeman MP, Rueter S, Zboyan HA, Diamond E, Cress KK, Marangell LB. Omega 3 fatty acids in bipolar disorder: a preliminary double-blind, placebo-controlled trial. Arch Gen Psychiatry. 1999 May;56(5):407-12. doi: 10.1001/archpsyc.56.5.407.
PubMed 10232294
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids in Bipolar Disorder Prophylaxis
- ClinicalTrials.gov ID
- NCT00010868
- Acronym / sponsor ID
- R01AT000161-02
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, omega-3 fatty acids, eicosapentaenoic acid, docosahexaenoic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Collaborators
- Pronova BioPharma
- Study start
- Jul 2000
- Study completion
- Jul 2004
- First posted
- 5 Feb 2001 (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.
This is a 12 month study of omega-3 fatty acids in bipolar disorder. This study will be a 12-month, parallel group, double-blind comparison of the prophylactic efficacy of omega-3 fatty acids vs. placebo in 120 bipolar I patients. All subjects entering the primary prophylactic study will be euthymic or have only subsyndromal mood symptoms for at least 4 weeks. In addition, their concomitant medication (only lithium, divalproex, or no medication will be permitted) will also be stable and at accepted therapeutic levels for at least 4 weeks. An 8-week lead-in phase will be available to subjects who do not meet the current symptom and concomitant medication inclusion criteria (however, subjects must meet all of the other inclusion/exclusion criteria): 1. 4 weeks of euthymic or subsyndromal mood. 2. Subjects who are not already receiving lithium or divalproex. 3. Subjects receiving other psychotropic medications.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet DSM-IV criteria for bipolar disorder, type I.
- Have had an episode of mania, hypomania, mixed mania, or major depression within the preceding 12 months, as defined by SCID criteria.
- Able to give informed consent.
Key exclusion criteria (8 listed)
- Patients with significant medical co-morbidity, such as active hepatic or renal disease, any type of coagulopathy, lipidoses, dementia, history of significant head injury, active cancer or cancer treatment, or other medical problems which may interfere with the absorption and metabolism of omega-3 fatty acids. In addition, any medical disorder with symptoms (e.g. aphasia, encephalopathy, etc.) which would make it difficult to determine the clinical response to the study drugs.
- Patients with significant psychiatric co-morbidity, such as another currently active Axis 1 or 2 disorder requiring treatment. Patients with other, active mental disorders may have psychiatric symptoms that would make it difficult to assess mood response to the study drugs. For example, a patient with significant anxiety or panic symptoms requiring medication would be excluded, whereas a patient with past or currently very mild anxiety symptoms not requiring active treatment would be eligible.
- Patients receiving Coumadin, or other drugs with strong effects on coagulation will be excluded due to the theoretical increased risk of bleeding on omega-3 fatty acid therapy. Low dose or intermittent NSAIDs will be permitted.
- Patients receiving drugs which affect lipid metabolism, such as HMG CoA inhibitors, high-dose niacin, gemfibrozil, and others.
- Pregnant patients - due to the unknown effects of high dose omega-3 fatty acids on the fetus.
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 |
|---|---|---|
| Omega-3 Fatty Acids | Drug | – |
Primary outcome
Not reported in the source record.
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 18 Aug 2006.
- Background: PubMed 10232294Stoll AL, Severus WE, Freeman MP, Rueter S, Zboyan HA, Diamond E, Cress KK, Marangell LB. Omega 3 fatty acids in bipolar disorder: a preliminary double-blind, placebo-controlled trial. Arch Gen Psychiatry. 1999 May;56(5):407-12. doi: 10.1001/archpsyc.56.5.407.
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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.
Andrew L. Stoll, M.D. principal investigator
Mclean Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 Fatty Acids in people with Bipolar Disorder, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites 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 3 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 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00010868, which also lists 1 linked publication.
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 18 Aug 2006.