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Ensayo controlado aleatorizado2013

Randomized placebo-controlled adjunctive study of an extract of withania somnifera for cognitive dysfunction in bipolar disorder

Chengappa KN, Bowie CR, Schlicht PJ, Fleet D, Brar JS, Jindal R

The Journal of clinical psychiatry · 73 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
National Alliance for Research on Schizophrenia and Depression

Según 1 financiador declarado.

Publicación

Publicado
2013-11-15 · J Clin Psychiatry · vol. 74 · número 11 · págs. 1076–1083
Editorial
Physicians Postgraduate Press, Inc.
Citado
120 citas · más que el 90% de estudios similares · 3.0× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
50 trabajos
Acceso
Lectura gratuita
Áreas de investigación
Bipolar Disorder and Treatment · Phytochemicals and Medicinal Plants · Schizophrenia research and treatment
Palabras clave
Withania somnifera, ashwagandha extract, bipolar disorder, cognitive impairment, working memory, backward digit span, reaction time, social cognition, adjunctive therapy, herbal medicine, maintenance therapy, flanker task, adverse events, treatment-resistant bipolar disorder
MeSH
humans, withania, antimanic agents, plant extracts, drugs, investigational, phytotherapy, drug therapy, combination, double-blind method, memory, short-term, attention, reaction time, cognition disorders, bipolar disorder, neuropsychological tests, psychometrics, adult, middle aged, female, male, executive function

6 autores

  • K. N. Roy Chengappa🇺🇸 · autor de correspondenciaUniversity of Pittsburgh Medical Center
  • Christopher R. Bowie🇺🇸University of Pittsburgh Medical Center
  • Patricia J. Schlicht🇺🇸University of Pittsburgh Medical Center
  • David Fleet🇺🇸University of Pittsburgh Medical Center
  • Jaspreet Singh Brar🇺🇸University of Pittsburgh Medical Center
  • Ripu Daman Jindal🇺🇸University of Pittsburgh Medical Center

Resumen

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

Objective

Cognitive impairments contribute significantly to inadequate functional recovery following illness episodes in bipolar disorder, yet data on treatment interventions are sparse. We assessed the cognitive effects of a standardized extract of the medicinal herb Withania somnifera (WSE) in bipolar disorder.

Method

Sixty euthymic subjects with DSM-IV bipolar disorder were enrolled in an 8-week, double-blind, placebo-controlled, randomized study of WSE (500 mg/d) as a procognitive agent added adjunctively to the medications being used as maintenance treatment for bipolar disorder. Study enrollment and data analyses were completed between December 2008 and September 2012. Cognitive testing at baseline and 8 weeks assessed primary efficacy outcomes. Psychopathology and adverse events were monitored at scheduled visits.

Results

Fifty-three patients completed the study (WSE, n = 24; placebo, n = 29), and the 2 groups were matched in terms of demographic, illness, and treatment characteristics. Compared to placebo, WSE provided significant benefits for 3 cognitive tasks: digit span backward (P = .035), Flanker neutral response time (P = .033), and the social cognition response rating of the Penn Emotional Acuity Test (P = .045). The size of the WSE treatment effect for digit span backward was in the medium range (Cohen d = 0.51; 95% CI, 0.25-0.77). None of the other cognitive tasks showed significant between-group differences. Mood and anxiety scale scores remained stable, and adverse events were minor.

Conclusions

Although results are preliminary, WSE appears to improve auditory-verbal working memory (digit span backward), a measure of reaction time, and a measure of social cognition in bipolar disorder. Given the paucity of data for improving cognitive capacity in bipolar disorder, WSE offers promise, appears to have a benign side-effects profile, and merits further study.

Trial registration

ClinicalTrials.gov identifier: NCT00761761.

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

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