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. 2021 Dec 21;326(23):2385–2394. doi: 10.1001/jama.2021.21187

Table 2. 8-Item Patient Health Questionnaire (PHQ-8) Depression Scale Mood Scores Each Year Since Randomization vs Baselinea.

Omega-3 group Placebo group Mean difference in change (95% CI)c P value P value for interactiond
No. of participants Adjusted mean (95% CI)b No. of participants Adjusted mean (95% CI)b
Baseline 9171 1.09 (1.06 to 1.13) 9182 1.11 (1.08 to 1.15)
Year 1 vs baseline 8471 0.05 (0.01 to 0.09) 8549 0.01 (−0.02 to 0.05) 0.03 (−0.02 to 0.09) .21
Year 2 vs baseline 8354 0.07 (0.03 to 0.11) 8371 0.04 (0.00 to 0.08) 0.03 (−0.03 to 0.08) .38
Year 3 vs baseline 8116 0.10 (0.06 to 0.15) 8172 0.06 (0.02 to 0.10) 0.05 (−0.01 to 0.10) .13
Year 4 vs baseline 7676 0.08 (0.04 to 0.12) 7690 0.05 (0.01 to 0.09) 0.03 (−0.03 to 0.09) .29
Year 5 vs baseline 5295 0.18 (0.13 to 0.23) 5252 0.19 (0.13 to 0.24) −0.01 (−0.08 to 0.06) .79 .52
1- to 5-y Average vs baseline 9171 9182 0.03 (−0.01 to 0.07) .19
a

Assesses the severity of depressive symptoms (range, 0-24). Higher scores indicate higher severity of depression. The prespecified minimal clinically important difference for change in score was 0.5. Distribution of PHQ-8 scores in omega-3 fatty acid and placebo groups by study year is provided eFigure 4 in Supplement 2. Analyses were from general linear models of response profiles to estimate the means, with time modeled as indicator variables; models were controlled for age, sex, and vitamin D3 randomization group.

b

Adjusted means (95% CI) within each treatment group are shown at baseline and adjusted mean differences in change (95% CI) within each treatment group are shown for each follow-up time point. The repeated measures model used all available responses and can handle missing outcome data, which were assumed missing at random.

c

Net difference in change comparing the omega-3 fatty acid and placebo groups from the repeated measures model. The final row shows the main outcome of the net difference between treatment groups in PHQ-8 change scores averaged across all follow-up years (years 1-5) from the repeated measures model; all participants contributed data to the repeated measures analysis at 1 or more times.

d

The P value for interaction is from the test of the 5 degree-of-freedom treatment × time interaction term in the model.