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Trial record 2 of 2 for:    12888186 [PUBMED-IDS]

Do Omega-3 Fatty Acids Have an Antidepressant Effect in Patients With Signs of Peripheral Inflammation?

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ClinicalTrials.gov Identifier: NCT03143075
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Region Skane

Brief Summary:

In this study, the investigators will stratify depressed subjects a priori based on CRP levels to test the hypothesis that eicosapentaenoic (EPA) would be more efficacious to treat depression in subjects with high CRP levels compared to subjects with low CRP levels.

Depressed subjects, with ongoing stabilized antidepressive treatment who remain clinically depressed, will be enrolled in an "Inflammation group" or in a "Non-inflammation group" depending on baseline levels of CRP. Subjects in both groups will receive EPA enriched omega-3 fatty acids for 8 weeks, added to their pre-stabilized antidepressant medication.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Dietary Supplement: Eicosapentaenoic acid enriched omega-3 fatty acids, 2 g/day Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Match/mismatch design (based on CRP levels), all subjects receive the same dose of EPA, no one receives placebo. Raters are blind to "Inflammation group" or "Non-inflammation group" allocation
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Raters are blind to "Inflammation group" or "Non-inflammation group" allocation
Primary Purpose: Treatment
Official Title: Do Omega-3 Fatty Acids Have an Antidepressant Effect in Patients With Signs of Peripheral Inflammation?
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Active Comparator: Inflammation group
Subjects with CRP≥3, will receive eicosapentaenoic acid enriched omega-3 fatty acids, 2 g/day, for 8 weeks, added to their pre-stabilized antidepressant medication
Dietary Supplement: Eicosapentaenoic acid enriched omega-3 fatty acids, 2 g/day
Eicosapentaenoic acid enriched omega-3 fatty acids, 2 g/day, added to pre-stabilized antidepressant medication

Active Comparator: Non-inflammation group
Subjects with CRP<3, will receive eicosapentaenoic acid enriched omega-3 fatty acids, 2 g/day, for 8 weeks, added to their pre-stabilized antidepressant medication
Dietary Supplement: Eicosapentaenoic acid enriched omega-3 fatty acids, 2 g/day
Eicosapentaenoic acid enriched omega-3 fatty acids, 2 g/day, added to pre-stabilized antidepressant medication




Primary Outcome Measures :
  1. Reduction in depressive symptoms [ Time Frame: 8 weeks ]
    Absolute difference between baseline and week 8 of the total sum of the HAM-D-17


Secondary Outcome Measures :
  1. Response [ Time Frame: 8 weeks ]
    Clinical "response" is defined as a 50% or greater reduction in depressive symptoms after treatment.

  2. Change in depressed mood [ Time Frame: 8 weeks ]
    Change in score on HAM-D-17 item # 1 "Depressed mood" (Hieronymus et al., 2015)

  3. Absolute change in "inflammatory depressive symptoms" [ Time Frame: 8 weeks ]
    Some depression symptoms such as anhedonia, fatigue and sleep or appetite disturbances may be more strongly linked with inflammation than others (Jokela, Virtanen et al. 2016, Miller, Haroon et al. 2016). "Inflammatory depressive symptoms", will defined as defined as a total composite score of the following items from the Patient Health Questionnaire-9 (PHQ-9)) (Kroenke, Spitzer et al. 2001): item 3 (sleep problems), item 4 (lack of energy), and item 5 (appetite disturbance).

  4. Improvement in functioning and quality of life. [ Time Frame: 8 weeks ]
    WHO Disability Assessment Schedule

  5. Absolute change in general Anxiety symptoms [ Time Frame: 8 weeks ]
    Generalized Anxiety Disorder-7 (GAD-7), self rating scale

  6. Absolute change in IL-6 and TNF-alpha [ Time Frame: 8 weeks ]
    IL-6, TNF-alpha (pg/ml)

  7. Absolute change in CRP, leptin, adiponectin [ Time Frame: 8 weeks ]
    CRP, leptin, adiponectin (mg/L)

  8. Absolute change in oxidative stress marker F2 Isoprostanes [ Time Frame: 8 weeks ]
    F2-Isoprostanes (ng/ml)

  9. Absolute change in oxidative stress marker 8-OHdG [ Time Frame: 8 weeks ]
    8-OH 2-deoxyguanosine (pmol/mikrog DNA)

  10. Absolute change in oxidative stress marker glutathione [ Time Frame: 8 weeks ]
    Glutathione (mikroM)

  11. Absolute change in metabolic markers [ Time Frame: 8 weeks ]
    Cholesterol, triglycerides, glucose (mg/dL)

  12. Absolute change in antioxidant glutathione peroxidase [ Time Frame: 8 weeks ]
    Glutathione peroxidase (nmole NADPH/ml/min)

  13. Absolute change in vascular cell adhesion molecule (VCAM) and intracellular adhesion molecule (ICAM) [ Time Frame: 8 weeks ]
    ICAM, VCAM (ng/ml)

  14. Absolute change in leukocyte telomerase activity [ Time Frame: 8 weeks ]
    leukocyte telomerase activity (units/10 000 cells)

  15. Absolute change in leukocyte telomere length [ Time Frame: 8 weeks ]
    leukocyte telomere length (base pairs)

  16. Absolute change in circulating cell-free mitochondrial DNA (ccf mtDNA) [ Time Frame: 8 weeks ]
    ccf mtDNA (units/mikrolitre plasma)

  17. Number of dropouts (due to side effects) [ Time Frame: 8 weeks ]
    Number of dropouts (due to side effects)

  18. Remission in depressive symptoms [ Time Frame: 8 weeks ]
    "Remission" is defined as post-treatment HAM-D-17 ratings of < 7



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male/female, aged 18-80.
  2. Fulfilling the DSM criteria for a current depressive episode, unipolar (symptom duration> 4 weeks) as determined by the study physician
  3. HAM-D-17 score ≥ 15 (Rapaport, Nierenberg et al. 2016)
  4. A Clinical Global Impression Severity Score ≥ 3 (Rapaport, Nierenberg et al. 2016)
  5. All subjects should be stable on antidepressants or mood stabilizers ≥6 weeks.
  6. Willing to not significantly modify their diet from the time they sign consent through the end of study participation.

Exclusion Criteria:

  1. Serious or unstable medical illness that in the investigator's opinion could compromise response to treatment or interpretation of study results. Examples: Malignancy not in remission for at least 1 year, Active autoimmune disorder or inflammatory bowel disease, Insulin-dependent diabetes mellitus.
  2. Known or suspected allergy to the study compounds.
  3. Ongoing infection.
  4. Ongoing pregnancy or breast-feeding
  5. A diagnosis of psychotic disorder, bipolar disorder, mental retardation dementia, or individual whom, due to other causes, lack the ability to make an informed decision.
  6. Ongoing ECT.
  7. Concomitant use of anticoagulants or known bleeding disorder.
  8. Patients who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk.
  9. A diagnosis for any Substance Use Disorder (except nicotine or caffeine) in the 3 months prior to the screening visit.
  10. Any medications (within 1 week of baseline or during the trial) that might confound the biomarker findings, including: Regular ingestion of NSAIDs or COX-2 inhibitors, or any use of oral steroids, immunosuppressants, interferon, chemotherapy (Patients will be instructed not to take an NSAID, COX-2 inhibitor or Aspirin in the 24 hours prior to a biomarker assessment visit).
  11. Patients who have taken supplements with omega-3 fatty acids for more than three consecutive days in the preceding month.
  12. Within 4 weeks of starting psychotherapy or planning to start psychotherapy during the study
  13. Active participation in other clinical studies with ongoing study visits


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): NCT03143075


Contacts
Contact: Daniel Lindqvist, MD, PhD +46-46-173885 Daniel.lindqvist@med.lu.se
Contact: Johan Olsson, RS +46-46-17 48 01 Johan.I.Olsson@skane.se

Locations
Sweden
Lund University, Dept of Psychiatry Recruiting
Lund, Sweden, 221 85
Contact: Daniel Lindqvist, MD, PhD    +46-46-173885    Daniel.lindqvist@med.lu.se   
Contact: Johan Olsson, RS    +46-46-17 48 01    Johan.I.Olsson@skane.se   
Sponsors and Collaborators
Region Skane
University of California, San Francisco

Publications:

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03143075     History of Changes
Other Study ID Numbers: 2017150
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Inflammation
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs