Depression Clinical Trial
— NutriMOODOfficial 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.
NCT number | NCT04844034 |
Other study ID # | SD001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 19, 2022 |
Est. completion date | December 2023 |
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.
Status | Recruiting |
Enrollment | 94 |
Est. completion date | December 2023 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 29 Years |
Eligibility | Inclusion Criteria: - Age 18-29 years - GAD-7 Score = 5 - PHQ-8 Score = 4 - English language fluency. - Overall good health. Exclusion Criteria: - 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. - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Roehampton | London |
Lead Sponsor | Collaborator |
---|---|
University of Roehampton |
United Kingdom,
Firth 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. — View Citation
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Kiecolt-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. — View Citation
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. — View Citation
Kroenke 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. — View Citation
LeBlanc, 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).
Masand 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. — View Citation
Mathias 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. — View Citation
McNamara 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. — View Citation
McNamara 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. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from Baseline in Dietary Protein on 24-hour Dietary Intake Recall at Week 12. | Intake24 will be used to capture 3 x 24-hour dietary intake recalls at baseline and endpoint to assess changes in dietary protein measured in grams (g). This is a validated web-based 24-hour dietary assessment tool for measuring dietary intake. | Baseline and Week 12. | |
Other | Change from Baseline in Dietary Energy on 24-hour Dietary Intake Recall at Week 12. | Intake24 will be used to capture 3 x 24-hour dietary intake recalls at baseline and endpoint to assess changes in dietary energy measured in kilocalories (kcal). This is a validated web-based 24-hour dietary assessment tool for measuring dietary intake. | Baseline and Week 12. | |
Other | Apolipoprotein E (APOE) and Fatty Acid Desaturase (FADS) Genotypes. | ApoE and FADs genotypes will be measured. | Baseline. | |
Other | Change from Baseline in Dietary Long-Chain Omega-3 Polyunsaturated Fatty Acids (LCn-3 PUFA) Intake at Week 12. | LCn-3 PUFA dietary intake changes will be assessed with a validated food frequency questionnaire (FFQ). | Baseline and Week 12. | |
Other | Change from Baseline in Whole Blood Fatty Acid Profile at Week 12. | Whole fatty acid composition will be measured. | Baseline and Week 12. | |
Other | Change from Baseline in Glutamate Concentrations in the Right and Left Ventrolateral Prefrontal Cortex and the Anterior Cingulate Cortex at Week 12. | Proton Magnetic resonance spectroscopy will be used to assess neurochemical changes in response to supplementation. | Baseline and Week 12. | |
Other | Change from Baseline in Seed-to-Voxel Functional Connectivity using Bilateral Orbitofrontal Cortex and Amygdala Seeds at Week 12. | Functional magnetic resonance imaging will be used to assess changes in functional connectivity in response to supplementation. | Baseline and Week 12. | |
Primary | 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). | Baseline and Week 12. | |
Secondary | 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). | Baseline and Week 12. | |
Secondary | 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. | Baseline and Week 12. | |
Secondary | 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. | Baseline and Week 12. | |
Secondary | 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. | Baseline and Week 12. | |
Secondary | 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. | Baseline and Week 12. | |
Secondary | 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). | Baseline and Week 12. |
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