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Randomized placebo-controlled adjunctive study of an extract of withania somnifera for cognitive dysfunction in bipolar disorder.
J Clin Psychiatry. 2013 Nov; 74(11):1076-83.JC

Abstract

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.

Authors+Show Affiliations

Comprehensive Recovery Services, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, 3811 O'Hara St, Pittsburgh, PA chengappakn@upmc.edu.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24330893

Citation

Chengappa, K N Roy, et al. "Randomized Placebo-controlled Adjunctive Study of an Extract of Withania Somnifera for Cognitive Dysfunction in Bipolar Disorder." The Journal of Clinical Psychiatry, vol. 74, no. 11, 2013, pp. 1076-83.
Chengappa KN, Bowie CR, Schlicht PJ, et al. Randomized placebo-controlled adjunctive study of an extract of withania somnifera for cognitive dysfunction in bipolar disorder. J Clin Psychiatry. 2013;74(11):1076-83.
Chengappa, K. N., Bowie, C. R., Schlicht, P. J., Fleet, D., Brar, J. S., & Jindal, R. (2013). Randomized placebo-controlled adjunctive study of an extract of withania somnifera for cognitive dysfunction in bipolar disorder. The Journal of Clinical Psychiatry, 74(11), 1076-83. https://doi.org/10.4088/JCP.13m08413
Chengappa KN, et al. Randomized Placebo-controlled Adjunctive Study of an Extract of Withania Somnifera for Cognitive Dysfunction in Bipolar Disorder. J Clin Psychiatry. 2013;74(11):1076-83. PubMed PMID: 24330893.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized placebo-controlled adjunctive study of an extract of withania somnifera for cognitive dysfunction in bipolar disorder. AU - Chengappa,K N Roy, AU - Bowie,Christopher R, AU - Schlicht,Patricia J, AU - Fleet,David, AU - Brar,Jaspreet S, AU - Jindal,Ripu, PY - 2013/02/07/received PY - 2013/05/03/accepted PY - 2013/12/17/entrez PY - 2013/12/18/pubmed PY - 2014/2/4/medline SP - 1076 EP - 83 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 74 IS - 11 N2 - 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. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/24330893/Randomized_placebo_controlled_adjunctive_study_of_an_extract_of_withania_somnifera_for_cognitive_dysfunction_in_bipolar_disorder_ L2 - http://www.psychiatrist.com/jcp/article/pages/2013/v74n11/v74n1107.aspx DB - PRIME DP - Unbound Medicine ER -