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Omega-3 Fatty Acids in Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omega-3 Fatty Acids
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar disorder, omega-3 fatty acids, eicosapentaenoic acid, docosahexaenoic acid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • McLean Hospital
  • Baylor College of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Pronova BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT00010868
Brief Title
Omega-3 Fatty Acids in Bipolar Disorder
Official Title
Omega-3 Fatty Acids in Bipolar Disorder Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Pronova BioPharma

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
bipolar disorder, omega-3 fatty acids, eicosapentaenoic acid, docosahexaenoic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Omega-3 Fatty Acids

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew L. Stoll, M.D.
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10232294
Citation
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.
Results Reference
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Omega-3 Fatty Acids in Bipolar Disorder

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