The Better Resiliency Among Veterans With Omega-3's (BRAVO) Study

NCT01901887 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: BRAVO2013
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The BRAVO study seeks to determine if dietary supplementation with omega-3 highly unsaturated fatty acids (omega-3 HUFAs) reduces the risk for serious suicidal behaviors, suicidal thinking, negative emotions, and symptoms associated with suicide risk, in a Veteran and non-Veteran population that is at risk for suicidal behaviors. This study seeks to evaluate the efficacy of omega-3 HUFAs among a representative population of US Veterans and non-Veterans already receiving appropriate medical care so that if successful, these results can be readily applied to broader populations in the US.

Conditions

Suicide

Keywords

Adults; Suicidality

Outcome Measures

Primary Outcomes (1)

• Impact of omega-3 HUFA supplementation on suicidal behaviors and thinking among adults.

  Examine to see if dietary supplementation with omega-3 HUFAs results in fewer episodes of a New Episode of Significant Suicide Risk (NESSR)\*, reduces symptom assessment scores for suicidality, reduces implicit associations with suicide and death, and improves performance scores on suicide related cognition tests. \* A NESSR is defined as the occurrence of any of the following: a) a suicide death, or b) a suicide attempt, or c) an inpatient admission with suicide risk, or d) a "new VA medical record flag for suicidality", or outside the VA system a clinical diagnostic equivalent (the Columbia-Suicide Severity Rating Scale) and psychiatrist review of participant medical history and physical.

  6 months

Secondary Outcomes (3)

• Impact of omega-3 HUFA supplementation on symptoms of negative affect associated with suicide risk among adults.

  6 months

• Impact of omega-3 HUFA supplementation on symptoms of post-traumatic stress disorder (PTSD) associated with suicide risk among adults.

  6 months

• Impact of omega-3 HUFA supplementation on symptoms of cognitive functioning associated with suicide risk among adults.

  6 months

Other Outcomes (4)

• Impact of omega-3 HUFA supplementation among subjects with moderate to severe depressive symptoms to evaluate efficacy for clinically significant depressive symptoms.

  6 months

• Impact of dietary supplementation with omega-3 fatty acids on alcohol consumption in suicidal adults with alcohol use disorders.

  6 months

• Impact of an omega-3 HUFA intervention on prefrontal hypo activation to risky decision-making and recall of past suicidal events in suicide attempters, using functional Magnetic Resonance Imaging (fMRI).

  6 months

Study Arms (2)

Study Juice

EXPERIMENTAL

3,300 mg of Omega-3 HUFAs per day for 6 months Other names: none

Drug: Study Juice

Placebo Juice

PLACEBO COMPARATOR

3,300 mg of macadamia nut oil per day for 6 months Other names: none

Drug: Placebo Juice

Interventions

Study Juice DRUG

The intervention will be 3 boxes/day for 6 months of SMARTFISH® Nutrifriend 1100, a commercially available smoothie juice box containing 1,100 mg of omega-3 HUFAs/200 ml box (approximately 550 mg EPA and 550 mg DHA/box) for a total of 3,300 mg of omega-3 HUFAs/day (approximately 1,650 mg EPA and 1,650 mg DHA/day).

Also known as: SMARTFISH® Nutrifriend 1100, Omega-3 formulated juice

Study Juice

Placebo Juice DRUG

The placebo will be 3 boxes/day for 6 months of a placebo juice which will be identical to the study juice except that it will substitute 1,100 mg of macadamia nut oil/200 ml juice box in place of the omega-3 HUFAs for a total of 3,300 mg of macadamia nut oil/day.

Also known as: Other names: Smartfish (placebo juice)

Placebo Juice

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a Veteran or non-Veteran identified as being at risk for suicide and presently under the care of a mental healthcare provider (A release of information from his/her mental healthcare provider is required.)
• age 18 - 90
• within the participant's medical history, either
• a suicide attempt in the last 6 months, or
• a suicide attempt during the adult lifetime AND current diagnosis of an episode of depression as diagnosed on the Mini International Neuropsychiatric Interview (MINI), or
• an inpatient admission with suicide risk in the last 6 months, or
• an inpatient admission with suicide risk during the adult lifetime AND current diagnosis of an episode of depression as diagnosed on the Mini International Neuropsychiatric Interview (MINI), or
• positive suicidal behavior or ideation based on a psychiatrist- administered Columbia-Suicide Severity Rating Scale (C-SSRS) and psychiatrist review of participant medical history and physical\], or
• a score of 0 or greater on the Implicit Associations Test-Suicide (IAT-S), or
• \> or = 9 on the Beck Hopelessness Scale (BHS) and psychiatrist review of participant medical history and physical
• participant can safely eat walnuts, pecans, almonds, peanuts and all other nuts
• participant can safely eat apples, peaches, pears, pomegranates, aronia, jackfruit, and passion fruit
• participant can safely eat the herb rosemary, and the fish salmon, trout and cod
• participant can safely drink and eat food that contain whey and/or milk protein
• willingness to drink the juice boxes 3 times each day for 6 months

You may not qualify if:

• unstable medical conditions requiring immediate attention or medical conditions that preclude potential study participation for the duration of the study
• history of seizures, except for:
• febrile seizures during childhood
• history of a single seizure episode as an adult if not being maintained on anti-seizure medication; this single seizure must not be related to a primary seizure disorder (must not be epilepsy)
• persons who have received a diagnosis of diabetes
• those taking Isotretinoin (Accutane)
• allergy, hypersensitivity, or intolerance to fish oils or omega-3 fats
• allergy, hypersensitivity, or intolerance to Macadamia nuts or any nuts such as almonds, walnuts, pecans, peanuts, etc.
• allergy, hypersensitivity, or intolerance to apples, peaches, pears, pomegranates, aronia, jackfruit, and passion fruit
• allergy, hypersensitivity, or intolerance to the herb rosemary, and the fish: salmon, trout and cod
• allergy, hypersensitivity, or intolerance to whey and/or milk protein
• life threatening medical conditions or life expectancy of less than 6 months
• pregnancy or lactation or intention to become pregnant within the next 12 months
• acute intoxication or withdrawal from alcohol or other substances (to be determined by a clinical team member)
• a cognitive impairment severe enough to preclude informed consent or valid responses on self-report questionnaires

Sponsors & Collaborators

• Medical University of South Carolina: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (6)

• Hibbeln JR. Fish consumption and major depression. Lancet. 1998 Apr 18;351(9110):1213. doi: 10.1016/S0140-6736(05)79168-6. No abstract available.

  PMID: 9643729 BACKGROUND

• Hibbeln JR, Linnoila M, Umhau JC, Rawlings R, George DT, Salem N Jr. Essential fatty acids predict metabolites of serotonin and dopamine in cerebrospinal fluid among healthy control subjects, and early- and late-onset alcoholics. Biol Psychiatry. 1998 Aug 15;44(4):235-42. doi: 10.1016/s0006-3223(98)00141-3.

  PMID: 9715354 BACKGROUND

• McNamara RK, Carlson SE. Role of omega-3 fatty acids in brain development and function: potential implications for the pathogenesis and prevention of psychopathology. Prostaglandins Leukot Essent Fatty Acids. 2006 Oct-Nov;75(4-5):329-49. doi: 10.1016/j.plefa.2006.07.010. Epub 2006 Sep 1.

  PMID: 16949263 BACKGROUND

• Blasbalg TL, Hibbeln JR, Ramsden CE, Majchrzak SF, Rawlings RR. Changes in consumption of omega-3 and omega-6 fatty acids in the United States during the 20th century. Am J Clin Nutr. 2011 May;93(5):950-62. doi: 10.3945/ajcn.110.006643. Epub 2011 Mar 2.

  PMID: 21367944 BACKGROUND

• Hibbeln JR. Depression, suicide and deficiencies of omega-3 essential fatty acids in modern diets. World Rev Nutr Diet. 2009;99:17-30. doi: 10.1159/000192992. Epub 2009 Jan 9. No abstract available.

  PMID: 19136836 BACKGROUND

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

  PMID: 33884617 DERIVED

MeSH Terms

Conditions

Suicide; Suicidal Ideation

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Bernadette Marriott, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Joseph R Hibbeln, MD

  LMBB, NIAAA, NIH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Department of Medicine

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 17, 2013
• Study Start: March 1, 2014
• Primary Completion: August 30, 2016
• Study Completion: August 30, 2016
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

US (1)