Safety and tolerability of divalproex sodium in the treatment of signs and symptoms of mania in elderly patients with dementia: results of a double-blind, placebo-controlled trial

Tariot, Pierre N.; Schneider, Lon S.; Mintzer, Jacobo; Cutler, Andrew J.; Cunningham, Muriel R.; Thomas, James W.; Sommerville, Kenneth W.

doi:10.1016/s0011-393x(01)80042-4

Cited by 106 publications

(62 citation statements)

References 28 publications

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“…A growing body of literature, including several doubleblind, placebo-controlled studies (Frankenberg and Zanarini, 2002;Hollander et al, 2001a;Tariot et al, 2001), supports a role for divalproex in the treatment of behavioral dyscontrol symptoms such as impulsivity, impulsive aggression, and hostility in a variety of psychiatric disorders. Divalproex improves symptoms of irritability and aggression in patients with personality disorders, in particular borderline personality disorder (Frankenberg et al, 2002;Hollander et al, 2001a;Kavoussi and Coccaro, 1998;Wilcox, 1995;Stein et al, 1995a).…”

Section: Introductionmentioning

confidence: 99%

“…Divalproex improves symptoms of irritability and aggression in patients with personality disorders, in particular borderline personality disorder (Frankenberg et al, 2002;Hollander et al, 2001a;Kavoussi and Coccaro, 1998;Wilcox, 1995;Stein et al, 1995a). In addition, improvements have been noted following treatment with divalproex in patients with behavioral dyscontrol following traumatic brain injury (Horne and Lindley, 1995), temper outbursts (Donavan et al, 1997(Donavan et al, , 2000Giakas et al, 1990), post-traumatic stress disorder (Petty et al, 2002;Fesler, 1991;Szymanski and Olympia, 1991), and agitation in the elderly (Tariot et al, 2001;Haas et al, 1997).…”

Section: Introductionmentioning

confidence: 99%

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Divalproex in the Treatment of Impulsive Aggression: Efficacy in Cluster B Personality Disorders

Hollander

Tracy

Swann

et al. 2003

Neuropsychopharmacol

238

157

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Impulsive aggressive behavior is common in psychiatric disorders and accounts for significant morbidity and mortality. However, little systematic treatment data exist from placebo-controlled trials for this symptom domain. This was a multicenter, randomized, doubleblind, placebo-controlled study in which outpatients with a score of X15 on the Aggression scale of the Overt Aggression ScaleModified (OAS-M) and who fulfilled DSM-IV criteria for Cluster B personality disorder (n ¼ 96), intermittent explosive disorder (n ¼ 116), or post-traumatic stress disorder (n ¼ 34) were randomized to divalproex sodium or placebo for 12 weeks duration. Based on average OAS-M Aggression scores over the last 4 weeks of treatment, a treatment effect was not observed in the intent-to-treat data set (combined across the three psychiatric disorders), but was observed in both intent-to-treat and evaluable data sets for patients with Cluster B personality disorders. In the Cluster B evaluable data set, statistically significant treatment differences favoring divalproex were also observed for component items of the OAS-M Aggression score, including verbal assault and assault against objects, as well as OAS-M Irritability score, and Clinical Global Impression (CGI)-Severity at multiple time points throughout the study. No treatment group difference was noted for overall premature discontinuation rate; however, across psychiatric diagnoses, 21 (17%) patients in the divalproex group prematurely discontinued because of an adverse event, as compared to 4 (3%) patients in the placebo group (po0.001). While a treatment effect was not observed when all diagnostic groups were combined, in a large subgroup of patients with Cluster B disorders, divalproex was superior to placebo in the treatment of impulsive aggression, irritability, and global severity.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Divalproex in the Treatment of Impulsive Aggression: Efficacy in Cluster B Personality Disorders

Hollander

Tracy

Swann

et al. 2003

Neuropsychopharmacol

238

157

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“…Sodium valproate has been shown as a promising agent in reducing the symptoms of mania by reducing the assessment scale scores in studies conducted by Ozcan et al (2001), Pope et al (1991) and Tariot et al (2001).…”

Section: Sodium Valproate As An Anti-manic Agentmentioning

confidence: 99%

Efficacy of Sodium Valproate and Olanzapine in treating bipolar affective disorder 'mania' at a tertiary care hospital in Nepal: A comparative study

Chaurasia¹,

Shah

Chetty

2017

Janaki Med. Coll. J. Med. Sci.

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Background and Objectives: Bipolar affective disorder, mania is the mood of an abnormally elevated arousal energy level or a state of heightened overall activation with enhanced affective expression together with lability of affect. The objective of the study was to compare the efficacy of sodium valproate and olanzapine in bipolar affective disorder, mania patients at a tertiary care hospital in NepalMaterial and Methods: A randomized observational prospective open label study was conducted for one and half year at College of Medical Sciences-Teaching Hospital (CMS-TH), Bharatpur, Nepal in the Psychiatry Department. Sixty patients diagnosed with bipolar affective disorder, mania were enrolled. 30 patients received sodium valproate and 30 patients received olanzapine. Patients were monitored and evaluated on baseline (day 0), day 7 and day 30 and compared to the baseline for the severity of illness using the 11-item Young Mania Rating Scale (YMRS).Results: The mean baseline YMRS score for all cases on sodium valproate (n=30) on day 0 was 38.87 ± 3.73, while it was reduced to 13.90 ± 1.95 (p < 0.001) on day 30. Similarly, the mean baseline YMRS score for all cases on olanzapine (n=30) on day 0was 40.83 ± 6.50, while it was reduced to 14.47 ± 2.83 (p < 0.001) on day 30.The mean decrease in YMRS score by sodium valproate was 64.24% and by olanzapine was 64.56%.Conclusion: Treatment with sodium valproate and olanzapine significantly improves the mean mania ratings score and there is no statistically significant difference in efficacy of both the drugs in patients diagnosed with bipolar affective disorder, mania.Janaki Medical College Journal of Medical Sciences (2016) Vol. 4(1): 27-35

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“…Himmelhoch [7] reported, for example, that among elderly patients, LI was poorly tolerated in those with dementia and in those with parkinsonian features. Anticonvulsant side effects may also be greater in elders with dementia, but, as is the case for LI [7], available reports have not included nondemented patients [70,71]. In a randomized double blind, placebo-controlled study of VAL, elderly patients with dementia and manic features had a discontinuation rate due to adverse events, primarily sedation, of 22% during initiation of treatment at doses greater than 15 mg/kg [70]; this suggests that demented patients tolerate lower doses than do nondemented patients.…”

Section: Neurological and Medical Comorbiditymentioning

confidence: 99%

“…Comorbid dementia may also be associated with worse antimanic outcomes of LI treatment [7]. In a randomized, placebo-controlled trial in demented patients with manic symptoms, VAL reduced agitation but not mania ratings [70].…”

Section: What Factors May Modify Acute Efficacy?mentioning

confidence: 99%

Evidence-Based Pharmacological Treatment of Geriatric Bipolar Disorder

Young

2005

Psychiatric Clinics of North America

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Safety and tolerability of divalproex sodium in the treatment of signs and symptoms of mania in elderly patients with dementia: results of a double-blind, placebo-controlled trial

Cited by 106 publications

References 28 publications

Divalproex in the Treatment of Impulsive Aggression: Efficacy in Cluster B Personality Disorders

Divalproex in the Treatment of Impulsive Aggression: Efficacy in Cluster B Personality Disorders

Efficacy of Sodium Valproate and Olanzapine in treating bipolar affective disorder 'mania' at a tertiary care hospital in Nepal: A comparative study

Evidence-Based Pharmacological Treatment of Geriatric Bipolar Disorder

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