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

NCT04210804 | Completed Phase 2

• 1 other identifier: 12/12
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Bipolar Depression

Keywords

Omega-3; Bipolar Disorder; Depression

Outcome Measures

Primary Outcomes (1)

• Episodes of Depression or Elation

  Documented episodes of depression or elation noted in clinical notes, or re-hospitalisation or treatment change secondary to episode of depression or elation

  15 months (duration of trial and 3 month follow-up)

Secondary Outcomes (4)

• Psychometric Measures of Depression or Elation

  15 months (duration of trial and 3 month follow-up)

• Adverse Effects

  15 months (duration of trial and 3 month follow-up)

• Continuation rate

  15 months (duration of trial and 3 month follow-up)

• Time to relapse of depression or elation

  15 months (duration of trial and 3 month follow-up)

Study Arms (2)

Omega-3

EXPERIMENTAL

1gEPA and 1gDHA in 200mls smoothie

Dietary Supplement: Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA)

Placebo

PLACEBO COMPARATOR

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)

Interventions

Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA) DIETARY_SUPPLEMENT

200mls Smoothie

Omega-3; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give written informed consent and comply with the study protocol.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

NUI Galway

Galway, Ireland

Location

Related Publications (46)

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MeSH Terms

Conditions

Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: One month placebo run in prior to randomisation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 26, 2019
• Study Start: April 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: January 1, 2018
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)