Depression Clinical Trial
Official title:
Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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