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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 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento

Quién lo pagó

Financiación
Financiación independiente
Organización sin fines de lucro
Universal Human Rights and Social Development Association (UHRSDA)

Según 1 financiador declarado.

Publicación

Publicado
2024-11-01 · Eur Neuropsychopharmacol · vol. 90 · págs. 28–35
Editorial
Elsevier BV
Citado
18 citas · más que el 95% de estudios similares · 4.1× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
52 trabajos
Acceso
Acceso abierto (revista híbrida) · CC-BY
Áreas de investigación
Diet and metabolism studies · Muscle metabolism and nutrition · Eating Disorders and Behaviors
Palabras clave
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 autores

  • Nima Norbu Sherpa🇬🇧Glasgow Caledonian University
  • Riccardo De Giorgi🇬🇧 · autor de correspondenciaWarneford Hospital
  • Edoardo Giuseppe Ostinelli🇬🇧Warneford Hospital
  • Amrita ChoudhurySt. Xavier's University Kolkata
  • Tenzin Dolma🇮🇳Uttarakhand Government
  • Sangila Dorjee🇮🇳Government of Sikkim; Tamil Nadu Government Multi Super Speciality Hospital

Resumen

El texto original del estudio, en el idioma en que se publicó.

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.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).

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