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Randomized Controlled Trial
. 2024 Oct 29;16(21):3688.
doi: 10.3390/nu16213688.

The Efficacy of Omega-3 Fatty Acids as the Monotherapy for Depression: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

Suet-Kei Wu  1   2 , Kai-Jie Yang  1 , Wen-Chun Liu  3 , Ikbal Andrian Malau  1   4 , Halliru Zailani  1   2 , Cheng-Ho Chang  5 , Shih-Yi Huang  6 , Jane Pei-Chen Chang  1   7   8 , Wei-Che Chiu  9   10 , Kuan-Pin Su  1   4   7   11
Affiliations
Randomized Controlled Trial

The Efficacy of Omega-3 Fatty Acids as the Monotherapy for Depression: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

Suet-Kei Wu et al. Nutrients. .

Abstract

Objective: Omega-3 polyunsaturated fatty acids (n-3 PUFAs) have demonstrated protective effects in major depressive disorder (MDD) patients receiving antidepressant treatment. However, there have been a few double-blind randomized controlled trials focused on n-3 PUFAs as monotherapy in MDD, and the outcomes have been mixed. This study aimed to assess the clinical effects of n-3 PUFAs monotherapy in patients with MDD.

Methods: A total of 60 patients with MDD participated in this 12-week double-blind randomized controlled trial. They were randomized to either the n-3 PUFAs group (n = 30; 3.2 g of eicosapentaenoic acid, EPA and docosahexaenoic acid, DHA per day) or the placebo group (n = 30; 3.2 g of soybean oil per day). The severity of depression was evaluated using the Hamilton Rating Scale for Depression (HRSD).

Results: The n-3 PUFAs group had a significantly lower HRSD score compared with the placebo group at week 4 (p = 0.004), week 6 (p = 0.006), week 8 (p = 0.004), and week 12 (p = 0.01). The n-3 PUFAs group showed slightly higher rates for both remission (26.7% vs. 10%, p = 0.095) and response (23.3% vs. 6.7%, p = 0.145) compared with the placebo group at week 12, but these differences did not reach statistical significance.

Conclusions: These findings suggested that monotherapy of n-3 PUFAs could improve depression and potentially serve as an alternative option for MDD patients.

Keywords: RCT; depression; monotherapy; n-3 PUFAs.

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Conflict of interest statement

The authors declare that they have no financial or other relationships that might lead to a conflict of interest.

Figures

Figure 1
Figure 1
Consolidated standards of reporting trials (CONSORT) patient selection flow chart of the study. This flow chart contains the screening process, randomization, treatment, and follow-up of the patients.
Figure 2
Figure 2
Evolution of the 21-item Hamilton Rating Scale for Depression (HRSD-21) between the n-3 PUFAs or placebo groups. The points represented the mean HRSD scores and the bars indicated the 95% confidence intervals (CI). The significant differences were observed at week 4 (p = 0.004), week 6 (p = 0.006), week 8 (p = 0.004), and week 12 (p = 0.01). The mixed model analysis showed the effect of treatment on HRSD scores may have varied over time and indicated that the interaction between treatment and time may have been marginally significant (F = 2.405, df = 5, 74.824, p = 0.045).
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