K N Roy Chengappa 1 , Christopher R Bowie , Patricia J Schlicht , David Fleet , Jaspreet S Brar , Ripu Jindal Show Affiliations »
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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. © Copyright 2013 Physicians Postgraduate Press, Inc.
RCT Entities: Population
Interventions
Outcomes
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. © Copyright 2013 Physicians Postgraduate Press, Inc.
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Year: 2013
PMID： 24330893 DOI： 10.4088/JCP.13m08413
Source DB: PubMed Journal: J Clin Psychiatry ISSN： 0160-6689 Impact factor: 4.384