Clinical trial NCT00122954: Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis
Official title: Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Depression
Keywords: Fatty Acids, Omega-3
Fish Oils
Complementary Therapies
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2005-07-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine whether fish oil can reduce depression in people with multiple sclerosis (MS) who are mild to moderately depressed and are currently taking antidepressant medication.

Study hypothesis: Three months of fish oil supplementation will improve depression scores on the Montgomery-Asberg depression rating scale (MADRS) or Beck Depression Inventory (BDI) better than placebo.

Detailed description: Depression occurs in 50% to 60% of all individuals with MS. Evidence suggests that the omega-3 fatty acids in fish oil supplements can significantly reduce depression with a low risk of side effects. Therefore, fish oil supplements may be a safe adjunctive therapy to improve the therapeutic benefits of antidepressants. This study will determine the effectiveness of fish oil supplements in reducing depression in MS patients who are taking antidepressant medication.

This study will last 3 months. Participants will be randomly assigned to receive either fish oil supplements or placebo daily for 3 months. At the end of 3 months, participants who show an improvement in their depressive symptoms will have the option to continue their treatment for an additional 3 months. Participants will do no respond to treatment will be excused from the study. All participants will remain on their antidepressants and MS medication throughout the study. Participants will have weekly study visits. At each visit, participants will be asked about their general health, and self-report scales will be used to assess depressive symptoms. Medication adherence will be monitored by pill counts and through red blood cell fatty acid analysis. Blood collection will occur at study start and at study completion.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of relapsing-remitting MS
* Diagnosis of depressive disorder
* Score between 11 and 30 on the Montgomery-Asberg Depression Rating Scale (MADRS)
* Score of 25 or greater on the Mini-Mental State Examination (MMSE)
* Currently taking antidepressant medication for at least 3 months prior to study entry

Exclusion Criteria:

* Currently taking fatty acid supplements
* Consume more than 6 oz of fish per week within 1 month prior to study entry
* Severe depression
* Suicidal thoughts
* Other psychological disorders
* Currently taking more than two types of antidepressants
* Any serious medical condition that would interfere with the study
* Worsening of MS symptoms or corticosteroid treatment within 1 month prior to study entry
* Current enrollment in another fish oil study
* Pregnancy

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: baseline to 3 months
Secondary outcomes:
measure: Quality of Life (SF-36)
timeFrame: baseline to 3 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Lynne Shinto, ND, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nemets B, Stahl Z, Belmaker RH. Addition of omega-3 fatty acid to maintenance medication treatment for recurrent unipolar depressive disorder. Am J Psychiatry. 2002 Mar;159(3):477-9. doi: 10.1176/appi.ajp.159.3.477.
citation: Su KP, Huang SY, Chiu CC, Shen WW. Omega-3 fatty acids in major depressive disorder. A preliminary double-blind, placebo-controlled trial. Eur Neuropsychopharmacol. 2003 Aug;13(4):267-71. doi: 10.1016/s0924-977x(03)00032-4.
citation: Peet M, Horrobin DF. A dose-ranging study of the effects of ethyl-eicosapentaenoate in patients with ongoing depression despite apparently adequate treatment with standard drugs. Arch Gen Psychiatry. 2002 Oct;59(10):913-9. doi: 10.1001/archpsyc.59.10.913.
citation: Shinto L, Marracci G, Mohr DC, Bumgarner L, Murchison C, Senders A, Bourdette D. Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study. PLoS One. 2016 Jan 22;11(1):e0147195. doi: 10.1371/journal.pone.0147195. eCollection 2016.