- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05774665
Specialized Pro-resolving Lipid Mediators and Treatment Resistant Depression
The goal of this clinical trial is to determine the impact of omega-3 fatty acids on the production of anti-inflammatory effects and clinical improvement in people with depression who have not responded well to standard antidepressant treatment. The main questions it seeks to answer are:
- Do omega-3 fatty acids added to ineffective antidepressant treatment increase production of compounds that reduce inflammation?
- Is the increase in these anti-inflammatory compounds associated with a stronger antidepressant effect?
Participants taking antidepressants that have not worked completely will be assigned at random for a 12-week period to one of the following:
- an omega-3 preparation
- an inactive placebo
During the course of the study, blood tests will be obtained for compounds associated with inflammation, and questionnaires to measure clinical improvement in depressive symptoms will be administered.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: David Mischoulon, MD, PhD
- Phone Number: 617-724-5198
- Email: dmischoulon@mgh.harvard.edu
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University School of Medicine
-
Contact:
- Boadie H Dunlop, MD
- Phone Number: 404-727-8474
- Email: Bdunlop@emory.edu
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Depression Clinical and Research Program at Massachusetts General Hospital
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- University of Utah
-
Contact:
- Mark H Rapaport, MD
- Phone Number: 801-587-8626
- Email: mark.rapaport@hsc.utah.edu
-
Contact:
- Becky Kinkead, PhD
- Phone Number: 801-587-0689
- Email: becky.kinkead@hsc.utah.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: 18 to 65 years
- Patients with treatment-resistant MDD who have not responded to at least 2 and no more than 5 antidepressant trials of at least 8 weeks duration during the current episode and have been on a current stable antidepressant regiment for at least 4 weeks. The diagnosis of MDD will be confirmed using the MINI and the historical failure to respond to antidepressant therapy will be documented using the Antidepressant Treatment Response Questionnaire (ATRQ), with failure to respond defined as less than 50% improvement by subject history.
- hs-CRP ≥ 3 mg/L and ≤ 10 mg/L
- BMI >25 kg/m2 and ≤ 40 kg/m2
- 17-item Hamilton Depression Rating Scale (HAM-D) score ≥15, and <25% decrease in score between screen and baseline
Exclusion Criteria:
Diagnostic Exclusions:
- Meeting lifetime DSM-5 criteria for: a neurocognitive disorder, psychotic disorder, bipolar disorder, obsessive compulsive disorder, bulimia nervosa, or anorexia nervosa in the 3 months prior to the screening; any substance use disorder (except for nicotine or caffeine use disorder).
- Patients who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk
- Presence of a serious or unstable medical illness, including insulin-dependent diabetes mellitus or bleeding disorder which, in the investigator's opinion, could compromise response to treatment, participant safety, or interpretation of study results.
- Currently breastfeeding, pregnant women, or women of childbearing ability, who do NOT agree to use a study approved method of birth control (described in the MOP) for the duration of the study.
- Currently or within 90 days of screen participating in another clinical trial (excluding large natural cohort trials such as 'All of Us').
Treatment and Concomitant Medication Exclusions:
- Failure to respond during the course of the current major depressive episode to >5 adequate antidepressant trials
- Current use of antipsychotic medications or lithium
- Having received ketamine therapy within 90 days of the screening visit
- Patients who have initiated psychotherapy ≤ 90 days prior to screening.Having received electroconvulsive therapy during the current depressive episode or within 6 months of the screening visit
- Concomitant use of any psychotropic agents within 2 weeks of the baseline visit, except for the ongoing antidepressant, prescription hypnotics, diphenhydramine, or a stable daily dose of a benzodiazepine.
- Concomitant medications that might confound the biomarker findings within 1 week of the baseline visit and during the trial, including: regular (i.e. more than three times per week) ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase (COX)-2 inhibitors; any use of oral steroids, immunosuppressants, interferon, chemotherapy, or anticoagulants.
Omega-3 Exclusions:
- A history of severe sensitivity to soy products, fish products, or PUFA supplements
- Patients who had taken supplements enriched with n-3 fatty acids within 60 days of the screening visit or who, at baseline, were consuming a diet containing > 3 g/day of n-3 fatty acids, or who consume > 2 meals of fatty fish per week.
- Having taken a supplement of ≥1 g/day of n-3 fatty acids for ≥6 weeks during the current major depressive episode
- Patients who have had either a poor response or intolerable side effects from n-3s in the past.
- Patients with the following conditions: - Patients with the following conditions: history of atrial fibrillation or atrial flutter, left ventricle hypertrophy, stroke, cardiovascular disease (including coronary artery disease, heart failure, and moderate or severe valve disease or prior valve procedure), uncontrolled hypertension, Crohn's disease, Irritable Bowel Syndrome-diarrhea type, history of gastric bypass surgery, history of cholecystectomy, recent/current history of bulimia with purging, use of prokinetic medications that affect GI transit time, and small intestinal bacterial overgrowth (SIBO)
- Sustained atrial fibrillation or atrial flutter of greater than 30 seconds detected by Holter monitor between V1 (screen) and V2 (baseline)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo capsules containing soybean oil (about 54% omega-6 and 6% omega-3, but no EPA or docosahexaenoic acid (DHA)), and matched to the ProEPA Xtra capsules in terms of appearance, odor, and taste.
|
Placebo consisting of soybean oil (about 54% omega-6 and 6% omega-3, but no EPA or docosahexaenoic acid (DHA)).
|
Experimental: Omega-3
Omega-3 fatty acid (ProEPA Xtra) capsules containing a total of 4 g/day of eicosapentaenoic acid (EPA), administered for 12 weeks.
|
Omega-3 fatty acid enriched for eicosapentaenoic acid (EPA)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
18-HEPE (18-hydroxy eicosapentaeoic acid) Change
Time Frame: 12 weeks
|
Evaluate change in plasma 18-HEPE (18-hydroxy eicosapentaeoic acid) levels associated with 12 weeks of 4 g/day EPA-enriched n-3 treatment vs placebo.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
18-HEPE (18-hydroxy eicosapentaeoic acid) Change in Treatment Responders
Time Frame: 12 weeks
|
To evaluate changes in plasma 18-HEPE (18-hydroxy eicosapentaeoic acid) level in relation to sustained clinical response status on the MADRS measure of depression severity.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark H Rapaport, MD, University of Utah
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R33AT012329 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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