Efficacy and safety profile of oral creatine monohydrate in add-on to cognitive-behavioural therapy in depression: An 8-week pilot, double-blind, randomised, placebo-controlled feasibility and exploratory trial in an under-resourced area.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 39488067 · doi:10.1016/j.euroneuro.2024.10.004
What was done
An 8-week pilot, double-blind, randomized, placebo-controlled exploratory trial evaluated oral creatine monohydrate as an add-on to cognitive-behavioral therapy (CBT) for depression in an under-resourced area. One hundred participants with depression (50 females; mean age 30.4 ± 7.4 years; mean baseline PHQ-9 score 17.6 ± 6.3) were randomized to creatine plus CBT (n = 50) or placebo plus CBT (n = 50). The primary outcome was change in Patient Health Questionnaire-9 (PHQ-9) score at week 8, analyzed via mixed-model repeated measures ANCOVA adjusted for age, sex, and baseline depression score. Dropouts and adverse event rates were assessed via logistic regression.
What was found
Depression scores decreased in both groups over 8 weeks, with significantly greater improvement in the creatine group (mean difference = -5.12 on the PHQ-9). Discontinuations from any cause, discontinuations due to adverse events, and the proportion of participants experiencing at least one adverse event were comparable between groups.
Why it matters
This study provides initial evidence that creatine monohydrate may safely augment cognitive-behavioral therapy for depression, presenting a potentially accessible, low-cost adjunctive treatment for under-resourced settings.
Limits
The trial was an 8-week pilot study with a relatively small sample size (n = 100). The abstract does not report the creatine dosage, exact p-values, confidence intervals, specific adverse events encountered, or long-term durability of benefit beyond 8 weeks.
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