Ethyl-eicosapentaenoic acid in first-episode psychosis: a randomized, placebo-controlled trial
Berger GE, Proffitt TM, McConchie M, Yuen H, Wood SJ, Amminger GP, Brewer W, McGorry PD
The Journal of clinical psychiatry · 92 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
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 no declarada
Publicación
- Publicado
- 2007-12-15 · J Clin Psychiatry · vol. 68 · número 12 · págs. 1867–1875
- Editorial
- Physicians Postgraduate Press, Inc.
- Citado
- 152 citas · más que el 96% de estudios similares · 5.8× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 58 trabajos
- Acceso
- De pago
- Áreas de investigación
- Schizophrenia research and treatment · Fatty Acid Research and Health · Treatment of Major Depression
- Palabras clave
- first-episode psychosis, omega-3 fatty acids, antipsychotic augmentation, non-affective psychosis, treatment response, antipsychotic tolerability, extrapyramidal symptoms, constipation, sexual side effects, omega-3 supplementation, omega-6 fatty acids, n-6/n-3 ratio, omega-3 index
- MeSH
- humans, eicosapentaenoic acid, antipsychotic agents, treatment outcome, severity of illness index, double-blind method, psychotic disorders, adolescent, adult, female, male
2 autores
- Gregor Emanuel Berger🇦🇺The University of Melbourne
- Tina Proffitt
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
To investigate if ethyl-eicosapentaenoic acid (E-EPA) augmentation improves antipsychotic efficacy and tolerability in first-episode psychosis (FEP).
Method
We performed a 12-week, randomized, double-blind, placebo-controlled trial of 2-g E-EPA augmentation in 80 FEP patients. Sixty-nine patients were eligible for analysis; a post hoc analysis was computed for a subgroup of nonaffective FEP patients (N = 53). The first participant was included in November 2000 and the last participant completed the trial in August 2003. Primary outcome measures were symptom change scores and time to first response, while tolerability measures and cumulative antipsychotic dose were secondary outcome measures.
Results
Analysis of covariance controlling for baseline symptoms found no significant mean difference between E-EPA and placebo at week 12 for symptom change scores. Cox regression analysis revealed a significant treatment by diagnosis interaction (p = .024) for time to first response favoring E-EPA in nonaffective psychosis. Post hoc analysis for cumulative response rates further confirmed a higher response rate at week 6 (42.9% [15/35] vs. 17.6% [6/34] for all participants, p = .036; 54.2% [13/24] vs. 17.2% [5/29] for the nonaffective psychosis subset, p = .008); however, the difference at week 12 was no longer significant. Analysis of secondary outcome measures revealed that E-EPA-augmented participants needed 20% less antipsychotic medication between weeks 4 through 6 (p = .03), had less extrapyramidal side effects in the initial 9 weeks (p < .05 for all participants and for all timepoints), and reported less constipation (p = .011) and fewer sexual side effects (p = .016) than those treated with antipsychotic medication alone.
Conclusion
The findings suggest that E-EPA may accelerate treatment response and improve the tolerability of antipsychotic medications. However, it was not possible to demonstrate a sustained symptomatic benefit of E-EPA in early psychosis, possibly due to a ceiling effect, since a high proportion of first-episode patients already achieve symptomatic remission with antipsychotic medication alone. Further controlled trials in nonaffective early psychosis seem warranted.
Trial registration
Australian Clinical Trials Registry identifier 12605000267651 (http://actr.org.au).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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