CompletedPhase 1Phase 2Relapsing MSNCT00122954

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Omega-3 fatty acids

Placebo or sham

  • Placebo

Results by group

Montgomery-Asberg Depression Rating Scale (MADRS)

baseline to 3 months

GroupValueIntervalNumber analysed
Placebo45.5 percentage of subjects16
Omega-3 Fatty Acids47.4 percentage of subjects15

Placebo

45.5

Omega-3 Fatty Acids

47.4

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo180 (0.0%)
Omega-3 Fatty Acids210 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Montgomery-Asberg Depression Rating Scale (MADRS)

    baseline to 3 months

    Mood and sleep

Other measures (1)

  • Quality of Life (SF-36)

    baseline to 3 months

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 18 to 85

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Jul 2005

    2. Main results due

      Jun 2009

    3. Finished

      Jun 2009

    4. Results posted

      Jan 2014

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