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
Sherpa NN, De Giorgi R, Ostinelli EG, Choudhury A, Dolma T, Dorjee S
European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 12 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- Nonprofit
- Universal Human Rights and Social Development Association (UHRSDA)
Based on 1 listed funder(s).
Publication
- Published
- 2024-11-01 · Eur Neuropsychopharmacol · vol. 90 · pp. 28–35
- Publisher
- Elsevier BV
- Cited
- 18 citations · more than 95% of similar papers · 4.1× the field average
- Impact
- Top 10% most cited in its field
- References
- 52 works
- Access
- Open access (hybrid journal) · CC-BY
- Research areas
- Diet and metabolism studies · Muscle metabolism and nutrition · Eating Disorders and Behaviors
- Keywords
- Double blind, Placebo, Medicine, Pilot trial, Depression (economics), Creatine, Physical therapy, Internal medicine, Randomized controlled trial, Alternative medicine, Pathology
- MeSH
- humans, creatine, treatment outcome, combined modality therapy, administration, oral, feasibility studies, pilot projects, double-blind method, depression, adult, middle aged, female, male, young adult, cognitive behavioral therapy
6 authors
From GB, IN
- Nima Norbu SherpaGlasgow Caledonian University
- Riccardo De Giorgi · correspondingWarneford Hospital
- Edoardo Giuseppe OstinelliWarneford Hospital
- Amrita ChoudhurySt. Xavier's University Kolkata
- Tenzin DolmaUttarakhand Government
- Sangila DorjeeGovernment of Sikkim; Tamil Nadu Government Multi Super Speciality Hospital
Abstract
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.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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