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