AnxietyNutriMOODNCT04844034
Effects of a High EPA Multinutrient Supplement on Negative Affect in Young Adults.
A study testing High-EPA multinutrient supplement. in people with Anxiety and Depression, run by University of Roehampton at 1 site in United Kingdom.
Trial summary
This is a 12-week-long, randomised, double-blind, placebo-controlled trial exploring the efficacy of a high-EPA multinutrient supplement in the management of sub-clinical anxiety and depression. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- High-EPA multinutrient supplement.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Apr 2022to Dec 2023
- Phase
- Interventional
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-29 years
- GAD-7 Score ≥ 5
- PHQ-8 Score ≥ 4
- English language fluency.
- Overall good health.
Who cannot join
- Self reported BMI ≥ 30 kg/m^2.
- Current tobacco smoker.
- Diagnosis of anxiety, depression/major depressive disorder episode, psychosis, schizophrenia, bipolar disorder, eating disorders, haemophilia, or life-threatening disease during the preceding six months from the beginning of the trial.
- Use of antidepressant drugs during the preceding six months from the beginning of the trial.
- Participation to psychological and/or behavioural interventions during the preceding six months from the beginning of the trial.
- Inability to ingest pills.
Show all 12Show fewer
- Pregnancy.
- Breastfeeding.
- Known allergy or intolerance to LCn-3 PUFAs, seafood and any of the constituents of the supplement under investigation.
- High intake (more than twice per week) of oily fish (e.g. herring, pilchards, salmon, swordfish, sardines, sprats, trout or mackerel).
- Use of fish oil supplements during the preceding six months from the beginning of the trial.
- Inability to participate in the study for 12 consecutive weeks.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Roehampton
London, SW15 4JD
Jan Harrison, +44 (0) 20 8392 5785, ethics@roehampton.ac.uk
About this study
Official title: The Effects of a High Eicosapentaenoic Acid Multinutrient Supplement on Measures of Stress, Anxiety and Depression in Young Adults: a Randomised, Double-blind, Placebo-controlled Trial.
This is a 12-week-long, randomised, double-blind, placebo-controlled trial exploring the efficacy of a high-EPA multinutrient supplement in the management of sub-clinical anxiety and depression. The investigators focus on young and healthy, adult university students, who may otherwise not be eligible for pharmacological or cognitive behavioural therapy interventions.
Read the detailed description
First-line treatment for anxiety disorders comprises Cognitive Behavioural Therapy, which is ineffective in a considerable minority of individuals, and pharmacological treatments, which often confer significant side effects. On the other hand, fish-oil-based supplements have been shown to be safer, efficacious alternatives, especially for individuals not eligible for behavioural or pharmacological therapies. Evidence from randomised controlled trials (RCTs) suggests that the long-chain omega-3 polyunsaturated fatty acids (LCn-3 PUFAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) may exert beneficial anxiolytic effects. It is also suggested that dietary components such as vitamins and minerals e.g. a-tocopherol (vitamin E) and Magnesium (Mg), may also play a role in mood. It is furthermore theorised that minor allelic carriage of desaturase and apolipoprotein E (APOE) polymorphisms may also influence the putative anxiolytic potential of dietary components. However, despite the abundance of findings in RCTs and animal studies, the putative synergism, additive effects and precise mechanism of action of these macro- and micronutrients on anxiety in humans are largely unknown. Furthermore, the evidence suggests that in depressive states, glutamate homeostasis is dysregulated in frontal brain regions, and in bipolar patients, glutamate concentration is increased in the anterior cingulate cortex. Supplementation with EPA-rich regimes for 12 weeks confers beneficial changes in glutamate concentrations and improvement in functional connectivity between brain regions associated with mood and improvement in global symptoms.
The investigators have designed a randomised, double-blind, placebo-controlled trial to explore the above. Students from the University of Roehampton, aged 18-29 years (Emerging Adulthood), are randomised on a 1:1 allocation ratio, in two groups, for 12 weeks:
- Active treatment group to be supplemented with a high-EPA multinutrient supplement providing a daily dose of 1,125 mg EPA, 441 mg DHA, 330 mg magnesium and 7.5 mg α-tocopherol.
- Placebo group to be supplemented with an inert oil mix providing a daily dose of 3,060 mg sunflower seed oil, 60 mg lecithin, 300 mg glyceryl monostearate and 465 mg fish-oil (18%/12% EPA/DHA respectively) for blinding.
Brain hemodynamic and neurochemical changes in response to supplementation with the EPA-rich regime are explored in a subgroup of volunteers by magnetic resonance imaging (MRI). Analyses take place at the Combined Universities Brain Imaging Centre (CUBIC), Royal Holloway, University of London and comprise:
- Proton Magnetic resonance spectroscopy (MRS), to assess changes in glutamate concentrations in the right and left ventrolateral prefrontal cortex and the anterior cingulate cortex.
- Functional MRI (fMRI) to assess changes in seed-to-voxel functional connectivity using bilateral orbitofrontal cortex (OFC) and amygdala (AMY) seeds; regions in the brain implicated in the control of emotion and mood.
The choice of the population was made on the basis of its high-risk nature; university students in Emerging Adulthood (18-29 years of age) experience persistent levels of high-academic stress, social disconnection and sleep disruption which increase anxiety levels and exacerbate psychological distress and disengagement from study. University students are thus a high-risk, vulnerable group characterised by higher and increasing rates of anxiety disorders compared to the general population. Furthermore, this population is largely neglected by the therapeutic literature.
The study hypothesis is that:
- Generally healthy, non-clinically anxious university students in Emerging Adulthood experiencing sub-clinical levels of anxiety, will benefit from supplementation with a high-EPA multinutrient supplement, in that the latter will exert beneficial anxiolytic effects.
- Mg and vitamin E will exert additive anxiolytic effects.
- Interindividual variations in fatty acid desaturases (FADS) and APOE genotypes will influence the putative anxiolytic potential of the high-EPA multinutrient supplement under investigation.
- Prefrontal and anterior cingulate cortex glutamate concentrations, and functional connectivity between OFC and AMY, will improve in response to supplementation.
The investigators will perform mixed-model analysis of covariance for the study primary and secondary endpoints, on an intention-to-treat (ITT) and per-protocol (PP) basis. The investigation which will take place at the Department of Life Sciences of the University of Roehampton and the Combined Universities Brain Imaging Centre (CUBIC), Royal Holloway, University of London, harmonised with local and national guidelines and risk assessments, the code of Good Clinical Practice and the Declaration of Helsinki. The study findings will be reported in accordance with the CONSORT statement.
- Conditions
- Anxiety, Depression
- Being tested
- High-EPA multinutrient supplement., Placebo
- Keywords
- Anxiety, Depression, Anxiolytic, Antidepressant, Omega-3 PUFAs, Eicosapentaenoic Acid, Docosahexaenoic Acid, Long-chain Polyunsaturated Fatty Acids, Dietary Supplement, Stress, Functional magnetic resonance imaging, Magnetic resonance spectroscopy
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-EPA multinutrient supplement.Dietary supplement
Also called Libretto
Three capsules with the largest meal of the day providing:
- 1,125 mg EPA
- 441 mg DHA
- 330 mg Magnesium
- 7.5 mg a-tocopherol
PlaceboOther
Three capsules with the largest meal of the day providing:
- 3,060 mg sunflower seed oil
- 60 mg lecithin
- 300 mg glyceryl monostearate
- 465 mg EPA/DHA (18%/12% respectively for blinding)
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Active comparator | High-EPA multinutrient supplement. Receives: Dietary Supplement: High-EPA multinutrient supplement. |
| Placebo | Placebo comparator | Inert oil mix. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Anxiety on the 21-point Generalised Anxiety Disorder Assessment (GAD-7) at Week 12.
GAD-7 is a 7-item, validated, self-reported instrument used to screen for generalised anxiety disorder and to assess its severity over the past two weeks. Possible scores range from 0 (none) to 21 (severe).
Measured: Baseline and Week 12.
Secondary outcomes (6)
Change from Baseline in Depression on the 24-point Patient Health Questionnaire (PHQ-8) at Week 12.
PHQ-8 is an 8-item, validated, self-reported instrument used as a diagnostic and severity measure for depressive disorders. Possible scores range from 0 (none) to 24 (severe).
Measured: Baseline and Week 12.
Change from Baseline in Depression, Anxiety and Stress on the 21-item Depression, Anxiety and Stress Scale (DASS-21) at week 12.
DASS-21 is a validated tool comprising three self-report scales designed to measure the emotional states of depression, anxiety and stress.
Measured: Baseline and Week 12.
Change from Baseline in the Proportion of Trials Selected as Happy Compared to the Alternative Emotion, Adjusted to a Scale of 0 to 15 on the Emotional Bias Task (EBT) at Week 12.
EBT is a 4-minute-long, computer-based test that detects perceptual bias in facial emotion perception. The key outcome measure for the EBT is the bias point; the proportion of trials selected as happy compared to the alternative emotion, adjusted to a scale of 0 to 15. This is used to determine the extent and direction of the participant's bias. Additionally, latency measures and measures of how many times each emotion was selected are also available.
Measured: Baseline and Week 12.
Change from Baseline in Measures of Sustained Attention on the Rapid Visual Information Processing (RVP) at Week 12.
RVP is a 7-minute-long, computer-based test measuring sustained attention. Outcome measures cover latency (speed of response), probability of false alarms and sensitivity.
Measured: Baseline and Week 12.
Change from Baseline in Measures of Retention and Manipulation of Visuospatial Information on Spatial Working Memory (SWM) at Week 12.
SWM is a 4-minute-long, computer-based test that measures strategy and working memory errors as a measure of retention and manipulation of visuospatial information. Outcome measures include errors (selecting boxes that have already been found to be empty and revisiting boxes which have already been found to contain a token) and strategy.
Measured: Baseline and Week 12.
Change from Baseline in Measures of Response Inhibition on Stop Signal Task (SST) at Week 12.
SST is an up-to 14-minute-long, computer based test that measures response inhibition (impulse control). Outcome measures cover direction errors, proportion of successful stops, reaction time on Go trials, and stop signal reaction time (SSRT).
Measured: Baseline and Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start19 Apr 2022
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Simon Dyall, University of Roehampton
- Investigators
- Leigh Gibson, PhD, Study director, University of RoehamptonSimon Dyall, PhD, Principal investigator, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844034
- Sponsor's protocol ID
- SD001
- Acronym
- NutriMOOD
- Status last verified
- May 2023
- First submitted
- 16 Mar 2021
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be: * Fully anonymised * Stored for 8 years as per University of Roehampton's Research Ethics Committee guidelines and Code of Practice. * Appended to the final published report as supplemental material. * Available from the corresponding author upon request. * Handled, processed, stored and destroyed as per Data Protection Act (2018). * Collected in Microsoft Excel worksheets in one file per type of experiment including original and normalised values; images/graphs will be stored as .tiff or .jpg files. * Held encrypted on password-protected, university-owned drives. * Accessible only by the investigators. * Submitted for publication within one year. * Deposited in a public preprint server (e.g. bioRxiv). Additional files with legends explaining how the data has been saved and described will be prepared to allow replicability. All anonymised data volumes are expected to be small. Long-term backup/archiving will utilise secure in-house facilities and cloud-based storage.
Publications
Gravielle MC. Activation-induced regulation of GABAA receptors: Is there a link with the molecular basis of benzodiazepine tolerance? Pharmacol Res. 2016 Jul;109:92-100. doi: 10.1016/j.phrs.2015.12.030. Epub 2015 Dec 28.
PubMed 26733466Masand PS, Gupta S. Long-term side effects of newer-generation antidepressants: SSRIS, venlafaxine, nefazodone, bupropion, and mirtazapine. Ann Clin Psychiatry. 2002 Sep;14(3):175-82. doi: 10.1023/a:1021141404535.
PubMed 12585567Firth J, Teasdale SB, Allott K, Siskind D, Marx W, Cotter J, Veronese N, Schuch F, Smith L, Solmi M, Carvalho AF, Vancampfort D, Berk M, Stubbs B, Sarris J. The efficacy and safety of nutrient supplements in the treatment of mental disorders: a meta-review of meta-analyses of randomized controlled trials. World Psychiatry. 2019 Oct;18(3):308-324. doi: 10.1002/wps.20672.
PubMed 31496103O' Donovan F, Carney S, Kennedy J, Hayes H, Pender N, Boland F, Stanton A. Associations and effects of omega-3 polyunsaturated fatty acids on cognitive function and mood in healthy adults: a protocol for a systematic review of observational and interventional studies. BMJ Open. 2019 Jun 22;9(6):e027167. doi: 10.1136/bmjopen-2018-027167.
PubMed 31230010LeBlanc, N. J., Brown, M., & Henin, A. (2020). Anxiety Disorders in Emerging Adulthood. In E. Bui, M. E. Charney, & A. W. Baker (Eds.), (pp. 157-173).
Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
PubMed 18752852Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med. 2016 Jul-Aug;78(6):716-27. doi: 10.1097/PSY.0000000000000322.
PubMed 27187854Mathias RA, Pani V, Chilton FH. Genetic Variants in the FADS Gene: Implications for Dietary Recommendations for Fatty Acid Intake. Curr Nutr Rep. 2014 Jun;3(2):139-148. doi: 10.1007/s13668-014-0079-1.
PubMed 24977108Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Glaser R. Omega-3 supplementation lowers inflammation and anxiety in medical students: a randomized controlled trial. Brain Behav Immun. 2011 Nov;25(8):1725-34. doi: 10.1016/j.bbi.2011.07.229. Epub 2011 Jul 19.
PubMed 21784145McNamara RK, Strawn JR, Tallman MJ, Welge JA, Patino LR, Blom TJ, DelBello MP. Effects of Fish Oil Monotherapy on Depression and Prefrontal Neurochemistry in Adolescents at High Risk for Bipolar I Disorder: A 12-Week Placebo-Controlled Proton Magnetic Resonance Spectroscopy Trial. J Child Adolesc Psychopharmacol. 2020 Jun;30(5):293-305. doi: 10.1089/cap.2019.0124. Epub 2020 Mar 11.
PubMed 32167792McNamara RK, Li W, Lei D, Tallman MJ, Welge JA, Strawn JR, Patino LR, DelBello MP. Fish oil supplementation alters emotion-generated corticolimbic functional connectivity in depressed adolescents at high-risk for bipolar I disorder: A 12-week placebo-controlled fMRI trial. Bipolar Disord. 2022 Mar;24(2):161-170. doi: 10.1111/bdi.13110. Epub 2021 Jul 23.
PubMed 34214231Kelaiditis CF, Gibson EL, Dyall SC. The effects of a high eicosapentaenoic acid multinutrient supplement on measures of stress, anxiety and depression in young adults: Study protocol for NutriMOOD, a randomised double-blind placebo-controlled trial. Prostaglandins Leukot Essent Fatty Acids. 2021 Oct;173:102335. doi: 10.1016/j.plefa.2021.102335. Epub 2021 Aug 25.
PubMed 34461561
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a High Eicosapentaenoic Acid Multinutrient Supplement on Measures of Stress, Anxiety and Depression in Young Adults: a Randomised, Double-blind, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT04844034
- Acronym / sponsor ID
- NutriMOOD / SD001
- Conditions
- Anxiety, Depression
- Keywords
- Anxiety, Depression, Anxiolytic, Antidepressant, Omega-3 PUFAs, Eicosapentaenoic Acid, Docosahexaenoic Acid, Long-chain Polyunsaturated Fatty Acids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Apr 2021 (actual)
- 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-week-long, randomised, double-blind, placebo-controlled trial exploring the efficacy of a high-EPA multinutrient supplement in the management of sub-clinical anxiety and depression. The investigators focus on young and healthy, adult university students, who may otherwise not be eligible for pharmacological or cognitive behavioural therapy interventions.
Detailed description
First-line treatment for anxiety disorders comprises Cognitive Behavioural Therapy, which is ineffective in a considerable minority of individuals, and pharmacological treatments, which often confer significant side effects. On the other hand, fish-oil-based supplements have been shown to be safer, efficacious alternatives, especially for individuals not eligible for behavioural or pharmacological therapies. Evidence from randomised controlled trials (RCTs) suggests that the long-chain omega-3 polyunsaturated fatty acids (LCn-3 PUFAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) may exert beneficial anxiolytic effects. It is also suggested that dietary components such as vitamins and minerals e.g. a-tocopherol (vitamin E) and Magnesium (Mg), may also play a role in mood. It is furthermore theorised that minor allelic carriage of desaturase and apolipoprotein E (APOE) polymorphisms may also influence the putative anxiolytic potential of dietary components. However, despite the abundance of findings in RCTs and animal studies, the putative synergism, additive effects and precise mechanism of action of these macro- and micronutrients on anxiety in humans are largely unknown. Furthermore, the evidence suggests that in depressive states, glutamate homeostasis is dysregulated in frontal brain regions, and in bipolar patients, glutamate concentration is increased in the anterior cingulate cortex. Supplementation with EPA-rich regimes for 12 weeks confers beneficial changes in glutamate concentrations and improvement in functional connectivity between brain regions associated with mood and improvement in global symptoms.
The investigators have designed a randomised, double-blind, placebo-controlled trial to explore the above. Students from the University of Roehampton, aged 18-29 years (Emerging Adulthood), are randomised on a 1:1 allocation ratio, in two groups, for 12 weeks:
- Active treatment group to be supplemented with a high-EPA multinutrient supplement providing a daily dose of 1,125 mg EPA, 441 mg DHA, 330 mg magnesium and 7.5 mg α-tocopherol.
- Placebo group to be supplemented with an inert oil mix providing a daily dose of 3,060 mg sunflower seed oil, 60 mg lecithin, 300 mg glyceryl monostearate and 465 mg fish-oil (18%/12% EPA/DHA respectively) for blinding.
Brain hemodynamic and neurochemical changes in response to supplementation with the EPA-rich regime are explored in a subgroup of volunteers by magnetic resonance imaging (MRI). Analyses take place at the Combined Universities Brain Imaging Centre (CUBIC), Royal Holloway, University of London and comprise:
- Proton Magnetic resonance spectroscopy (MRS), to assess changes in glutamate concentrations in the right and left ventrolateral prefrontal cortex and the anterior cingulate cortex.
- Functional MRI (fMRI) to assess changes in seed-to-voxel functional connectivity using bilateral orbitofrontal cortex (OFC) and amygdala (AMY) seeds; regions in the brain implicated in the control of emotion and mood.
The choice of the population was made on the basis of its high-risk nature; university students in Emerging Adulthood (18-29 years of age) experience persistent levels of high-academic stress, social disconnection and sleep disruption which increase anxiety levels and exacerbate psychological distress and disengagement from study. University students are thus a high-risk, vulnerable group characterised by higher and increasing rates of anxiety disorders compared to the general population. Furthermore, this population is largely neglected by the therapeutic literature.
The study hypothesis is that:
- Generally healthy, non-clinically anxious university students in Emerging Adulthood experiencing sub-clinical levels of anxiety, will benefit from supplementation with a high-EPA multinutrient supplement, in that the latter will exert beneficial anxiolytic effects.
- Mg and vitamin E will exert additive anxiolytic effects.
- Interindividual variations in fatty acid desaturases (FADS) and APOE genotypes will influence the putative anxiolytic potential of the high-EPA multinutrient supplement under investigation.
- Prefrontal and anterior cingulate cortex glutamate concentrations, and functional connectivity between OFC and AMY, will improve in response to supplementation.
The investigators will perform mixed-model analysis of covariance for the study primary and secondary endpoints, on an intention-to-treat (ITT) and per-protocol (PP) basis. The investigation which will take place at the Department of Life Sciences of the University of Roehampton and the Combined Universities Brain Imaging Centre (CUBIC), Royal Holloway, University of London, harmonised with local and national guidelines and risk assessments, the code of Good Clinical Practice and the Declaration of Helsinki. The study findings will be reported in accordance with the CONSORT statement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Active comparator | Dietary Supplement: High-EPA multinutrient supplement.High-EPA multinutrient supplement. |
| Placebo | Placebo comparator | Other: PlaceboInert oil mix. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-29 years
- GAD-7 Score ≥ 5
- PHQ-8 Score ≥ 4
- English language fluency.
- Overall good health.
Key exclusion criteria (12 listed)
- Self reported BMI ≥ 30 kg/m^2.
- Current tobacco smoker.
- Diagnosis of anxiety, depression/major depressive disorder episode, psychosis, schizophrenia, bipolar disorder, eating disorders, haemophilia, or life-threatening disease during the preceding six months from the beginning of the trial.
- Use of antidepressant drugs during the preceding six months from the beginning of the trial.
- Participation to psychological and/or behavioural interventions during the preceding six months from the beginning of the trial.
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 |
|---|---|---|
| High-EPA multinutrient supplement.Also: LibrettoThree capsules with the largest meal of the day providing: * 1,125 mg EPA * 441 mg DHA * 330 mg Magnesium * 7.5 mg a-tocopherol | Dietary supplement | Active treatment |
| PlaceboThree capsules with the largest meal of the day providing: * 3,060 mg sunflower seed oil * 60 mg lecithin * 300 mg glyceryl monostearate * 465 mg EPA/DHA (18%/12% respectively for blinding) | Other | Placebo |
Primary outcome
Change from Baseline in Anxiety on the 21-point Generalised Anxiety Disorder Assessment (GAD-7) at Week 12.
Time frame: Baseline and Week 12.
GAD-7 is a 7-item, validated, self-reported instrument used to screen for generalised anxiety disorder and to assess its severity over the past two weeks. Possible scores range from 0 (none) to 21 (severe).
6 secondary outcomes
Change from Baseline in Depression on the 24-point Patient Health Questionnaire (PHQ-8) at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Depression, Anxiety and Stress on the 21-item Depression, Anxiety and Stress Scale (DASS-21) at week 12.
Time frame: Baseline and Week 12.
Change from Baseline in the Proportion of Trials Selected as Happy Compared to the Alternative Emotion, Adjusted to a Scale of 0 to 15 on the Emotional Bias Task (EBT) at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Measures of Sustained Attention on the Rapid Visual Information Processing (RVP) at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Measures of Retention and Manipulation of Visuospatial Information on Spatial Working Memory (SWM) at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Measures of Response Inhibition on Stop Signal Task (SST) at Week 12.
Time frame: Baseline and Week 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Background: PubMed 26733466Gravielle MC. Activation-induced regulation of GABAA receptors: Is there a link with the molecular basis of benzodiazepine tolerance? Pharmacol Res. 2016 Jul;109:92-100. doi: 10.1016/j.phrs.2015.12.030. Epub 2015 Dec 28.
- Background: PubMed 12585567Masand PS, Gupta S. Long-term side effects of newer-generation antidepressants: SSRIS, venlafaxine, nefazodone, bupropion, and mirtazapine. Ann Clin Psychiatry. 2002 Sep;14(3):175-82. doi: 10.1023/a:1021141404535.
- Background: PubMed 31496103Firth J, Teasdale SB, Allott K, Siskind D, Marx W, Cotter J, Veronese N, Schuch F, Smith L, Solmi M, Carvalho AF, Vancampfort D, Berk M, Stubbs B, Sarris J. The efficacy and safety of nutrient supplements in the treatment of mental disorders: a meta-review of meta-analyses of randomized controlled trials. World Psychiatry. 2019 Oct;18(3):308-324. doi: 10.1002/wps.20672.
- Background: PubMed 31230010O' Donovan F, Carney S, Kennedy J, Hayes H, Pender N, Boland F, Stanton A. Associations and effects of omega-3 polyunsaturated fatty acids on cognitive function and mood in healthy adults: a protocol for a systematic review of observational and interventional studies. BMJ Open. 2019 Jun 22;9(6):e027167. doi: 10.1136/bmjopen-2018-027167.
- BackgroundLeBlanc, N. J., Brown, M., & Henin, A. (2020). Anxiety Disorders in Emerging Adulthood. In E. Bui, M. E. Charney, & A. W. Baker (Eds.), (pp. 157-173).
- Background: PubMed 18752852Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
- Background: PubMed 27187854Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med. 2016 Jul-Aug;78(6):716-27. doi: 10.1097/PSY.0000000000000322.
- Background: PubMed 24977108Mathias RA, Pani V, Chilton FH. Genetic Variants in the FADS Gene: Implications for Dietary Recommendations for Fatty Acid Intake. Curr Nutr Rep. 2014 Jun;3(2):139-148. doi: 10.1007/s13668-014-0079-1.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 21784145Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Glaser R. Omega-3 supplementation lowers inflammation and anxiety in medical students: a randomized controlled trial. Brain Behav Immun. 2011 Nov;25(8):1725-34. doi: 10.1016/j.bbi.2011.07.229. Epub 2011 Jul 19.
- Background: PubMed 32167792McNamara RK, Strawn JR, Tallman MJ, Welge JA, Patino LR, Blom TJ, DelBello MP. Effects of Fish Oil Monotherapy on Depression and Prefrontal Neurochemistry in Adolescents at High Risk for Bipolar I Disorder: A 12-Week Placebo-Controlled Proton Magnetic Resonance Spectroscopy Trial. J Child Adolesc Psychopharmacol. 2020 Jun;30(5):293-305. doi: 10.1089/cap.2019.0124. Epub 2020 Mar 11.
- Background: PubMed 34214231McNamara RK, Li W, Lei D, Tallman MJ, Welge JA, Strawn JR, Patino LR, DelBello MP. Fish oil supplementation alters emotion-generated corticolimbic functional connectivity in depressed adolescents at high-risk for bipolar I disorder: A 12-week placebo-controlled fMRI trial. Bipolar Disord. 2022 Mar;24(2):161-170. doi: 10.1111/bdi.13110. Epub 2021 Jul 23.
- Individual participant dataSharing planned: Yes. Data will be: * Fully anonymised * Stored for 8 years as per University of Roehampton's Research Ethics Committee guidelines and Code of Practice. * Appended to the final published report as supplemental material. * Available from the corresponding author upon request. * Handled, processed, stored and destroyed as per Data Protection Act (2018). * Collected in Microsoft Excel worksheets in one file per type of experiment including original and normalised values; images/graphs will be stored as .tiff or .jpg files. * Held encrypted on password-protected, university-owned drives. * Accessible only by the investigators. * Submitted for publication within one year. * Deposited in a public preprint server (e.g. bioRxiv). Additional files with legends explaining how the data has been saved and described will be prepared to allow replicability. All anonymised data volumes are expected to be small. Long-term backup/archiving will utilise secure in-house facilities and cloud-based storage.
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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.
Leigh Gibson, PhD study director
University of Roehampton
Simon Dyall, PhD principal investigator
University of Roehampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-EPA multinutrient supplement. in people with Anxiety and Depression, run by University of Roehampton at 1 site in United Kingdom.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chris Kelaiditis, MSc (+447453264577, kelaidic@roehampton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Anxiety on the 21-point Generalised Anxiety Disorder Assessment (GAD-7) at Week 12. (time frame: Baseline and Week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04844034, which also lists 13 linked publications.
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 1 Jun 2023; AzTrials last refreshed its copy on 26 Oct 2026.