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.
Study Goal
The researchers aimed to investigate whether creatine monohydrate, as an adjunct to cognitive-behavioral therapy (CBT), could improve depression symptoms compared to placebo plus CBT.
Results Summary
Participants taking creatine showed significantly greater reduction in depression scores (PHQ-9) compared to placebo, with comparable rates of adverse events and treatment discontinuations between groups. The study suggests creatine may be a useful and safe supplement to CBT for depression.
Population
100 participants (50 females, mean age 30.4 ± 7.4 years) with depression (mean PHQ-9 score 17.6 ± 6.3).
Effective Dosage
Not specified
Duration
8 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
creatine monohydrate | neutral | - | - | - | could be a useful adjunct to conventional antidepressant treatments | #1 |
creatine in addition to cognitive-behavioural therapy (CBT) | decrease | Patient Health Questionnaire-9 depression score | participants with depression | - | PHQ-9 scores were lower | #2 |
creatine in addition to cognitive-behavioural therapy (CBT) | decrease | Patient Health Questionnaire-9 depression score | participants with depression | mean difference= -5.12 | significantly more so in participants taking creatine | #3 |
creatine in addition to cognitive-behavioural therapy (CBT) | no change | acceptability (any-cause dropouts) | participants with depression | - | Treatment discontinuations due to any cause were comparable | #4 |
creatine in addition to cognitive-behavioural therapy (CBT) | no change | tolerability (dropouts for adverse events) | participants with depression | - | dropouts for adverse events were comparable | #5 |
creatine in addition to cognitive-behavioural therapy (CBT) | no change | safety (patients experiencing one or more adverse events) | participants with depression | - | proportion of participants with at least one adverse event were comparable | #6 |
creatine | neutral | - | participants with depression | - | could be a useful and safe supplement to CBT for depression | #7 |
Pre-clinical and clinical evidence proposes that creatine monohydrate, an affordable nutraceutical, could be a useful adjunct to conventional antidepressant treatments. In this pilot feasibility and exploratory study, we investigate the 8-week effects of creatine in addition to cognitive-behavioural therapy (CBT) versus placebo plus CBT in depression. For the primary efficacy outcome of change in Patient Health Questionnaire-9 depression score at study endpoint, we used mixed-model repeated measures analysis of covariance. Logistic regressions were employed to assess acceptability (any-cause dropouts), tolerability (dropouts for adverse events), and safety (patients experiencing one or more adverse events). We calculated effect sizes adjusted for age, sex, and baseline depression score. One-hundred participants (50 females, mean age= 30.4 ± 7.4 years) with depression (mean PHQ-9 = 17.6 ± 6.3) were randomised to either creatine+CBT (N = 50) or placebo+CBT (N = 50). At 8 weeks, PHQ-9 scores were lower in both study arms, but significantly more so in participants taking creatine (mean difference= -5.12). Treatment discontinuations due to any cause and to adverse events, and proportion of participants with at least one adverse event were comparable between study arms. This hypothesis-generating trial suggests that creatine could be a useful and safe supplement to CBT for depression. Longer and larger clinical trials are warranted.