RECRUITING

Specialized Pro-resolving Lipid Mediators and Treatment Resistant Depression

Conditions

Treatment Resistant Depression Inflammation Overweight omega-3 fatty acid major depressive disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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: 1. Do omega-3 fatty acids added to ineffective antidepressant treatment increase production of compounds that reduce inflammation? 2. 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: 1. an omega-3 preparation 2. 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.

Official Title

Specialized Pro-resolving Lipid Mediators and Treatment Resistant Depression

Quick Facts

Study Start:2024-12-01

Study Completion:2026-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05774665

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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'). * 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. * 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)

Inclusion Criteria

Exclusion 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

* 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').
* 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.
* 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)

Contacts and Locations

Study Contact

David Mischoulon, MD, PhD

CONTACT

617-724-5198

dmischoulon@mgh.harvard.edu

Principal Investigator

Mark H Rapaport, MD

PRINCIPAL_INVESTIGATOR

University of Utah

Study Locations (Sites)

Emory University School of Medicine

Atlanta, Georgia, 30322

United States

Depression Clinical and Research Program at Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

University of Utah

Salt Lake City, Utah, 84108

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Mark H Rapaport, MD, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01

Study Completion Date2026-04-30

Study Record Updates

Study Start Date2024-12-01

Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

omega-3
fatty acid
major depressive disorder

Additional Relevant MeSH Terms

Treatment Resistant Depression
Inflammation
Overweight