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A Prophylactic Trial of Omega-3 Polyunsaturated Fatty Acids in Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04210804
Recruitment Status : Completed
First Posted : December 26, 2019
Last Update Posted : December 26, 2019
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Dr. Brian Hallahan, National University of Ireland, Galway, Ireland

Brief Summary:

This study is a 52 week double-blind placebo controlled study of omega-3 polyunsaturated fatty acids (PUFAs) in bipolar disorder (who have a history of 3 or more episodes) to ascertain if omega-3 PUFAs reduce the risk of further relapse for both / either depressive or (hypo)manic episodes.

This is a single-centre, 52 week, double-blind, randomised comparison of omega-3 PUFA (1g EPA and 1g DHA) versus placebo as adjunctive treatment in individuals with bipolar disorder


Condition or disease Intervention/treatment Phase
Bipolar Depression Dietary Supplement: Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: One month placebo run in prior to randomisation
Primary Purpose: Treatment
Official Title: A Prophylactic Trial of Omega-3 Polyunsaturated Fatty Acids in Bipolar Disorder
Actual Study Start Date : April 1, 2014
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Omega-3
1gEPA and 1gDHA in 200mls smoothie
Dietary Supplement: Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA)
200mls Smoothie

Placebo Comparator: Placebo
200mls smoothie without EPA or DHA. Looks and tastes identical to omega-3 arm
Dietary Supplement: Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA)
200mls Smoothie




Primary Outcome Measures :
  1. Episodes of Depression or Elation [ Time Frame: 15 months (duration of trial and 3 month follow-up) ]
    Documented episodes of depression or elation noted in clinical notes, or re-hospitalisation or treatment change secondary to episode of depression or elation


Secondary Outcome Measures :
  1. Psychometric Measures of Depression or Elation [ Time Frame: 15 months (duration of trial and 3 month follow-up) ]
    Change from baseline in psychometric instruments

  2. Adverse Effects [ Time Frame: 15 months (duration of trial and 3 month follow-up) ]
    Presence of adverse effects secondary to intervention or placebo

  3. Continuation rate [ Time Frame: 15 months (duration of trial and 3 month follow-up) ]
    Study engagement rates between intervention and placebo arms

  4. Time to relapse of depression or elation [ Time Frame: 15 months (duration of trial and 3 month follow-up) ]
    Time to relapse of depression or elation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to give written informed consent and comply with the study protocol.
  2. An established diagnosis of bipolar disorder (either type I or II) and have had at least 3 previous episodes of illness within the previous 5 years or 2 episodes in the last 12 months.

To be eligible for inclusion, each subject must meet each of the inclusion criteria at Screening (Visit 1) and must continue to fulfil these criteria at Baseline (Visit 2).

Exclusion Criteria:

  • Severity of their bipolar disorder is such that participation in a clinical trial is not appropriate because of the risk of imminent self-harm or psychiatric admission,
  • A concurrent medical condition (intracranial brain lesion),
  • Medication (steroids) that may be accounting for the mood episodes,
  • Participant is taking omega-3 PUFA supplements at the time of study entry or in the previous 12 weeks
  • Individuals who are participating in another study where they are receiving a different investigational agent during the course, or within the 12 week period prior to their inclusion in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04210804


Locations
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Ireland
NUI Galway
Galway, Ireland
Sponsors and Collaborators
National University of Ireland, Galway, Ireland
Stanley Medical Research Institute
Publications:

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Responsible Party: Dr. Brian Hallahan, Senior Lecturer, National University of Ireland, Galway, Ireland
ClinicalTrials.gov Identifier: NCT04210804    
Other Study ID Numbers: 12/12
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan for data sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Brian Hallahan, National University of Ireland, Galway, Ireland:
Omega-3
Bipolar Disorder
Depression
Additional relevant MeSH terms:
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Depression
Bipolar Disorder
Behavioral Symptoms
Mental Disorders
Bipolar and Related Disorders