Divalproex in the treatment of impulsive aggression

efficacy in cluster B personality disorders.

Eric Hollander, Katherine A. Tracy, Alan C. Swann, Emil F. Coccaro, Susan L. McElroy, Patricia Wozniak, Kenneth W. Sommerville, Charles Nemeroff

Research output: Contribution to journalArticle

195 Citations (Scopus)

Abstract

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, double-blind, placebo-controlled study in which outpatients with a score of > or =15 on the Aggression scale of the Overt Aggression Scale-Modified (OAS-M) and who fulfilled DSM-IV criteria for Cluster B personality disorder (n=96), intermittent explosive disorder (n=116), or post-traumatic stress disorder (n=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 (p <0.001). 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.

Original languageEnglish
Pages (from-to)1186-1197
Number of pages12
JournalNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology
Volume28
Issue number6
StatePublished - Jun 1 2003
Externally publishedYes

Fingerprint

Personality Disorders
Valproic Acid
Aggression
Placebos
Therapeutics
Psychiatry
Disruptive, Impulse Control, and Conduct Disorders
Impulsive Behavior
Post-Traumatic Stress Disorders
Mental Disorders
Diagnostic and Statistical Manual of Mental Disorders
Outpatients
Morbidity
Mortality

ASJC Scopus subject areas

  • Pharmacology

Cite this

Divalproex in the treatment of impulsive aggression : efficacy in cluster B personality disorders. / Hollander, Eric; Tracy, Katherine A.; Swann, Alan C.; Coccaro, Emil F.; McElroy, Susan L.; Wozniak, Patricia; Sommerville, Kenneth W.; Nemeroff, Charles.

In: Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, Vol. 28, No. 6, 01.06.2003, p. 1186-1197.

Research output: Contribution to journalArticle

Hollander, Eric ; Tracy, Katherine A. ; Swann, Alan C. ; Coccaro, Emil F. ; McElroy, Susan L. ; Wozniak, Patricia ; Sommerville, Kenneth W. ; Nemeroff, Charles. / Divalproex in the treatment of impulsive aggression : efficacy in cluster B personality disorders. In: Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology. 2003 ; Vol. 28, No. 6. pp. 1186-1197.
@article{f52da4905832412490f3226879eeee0d,
title = "Divalproex in the treatment of impulsive aggression: efficacy in cluster B personality disorders.",
abstract = "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, double-blind, placebo-controlled study in which outpatients with a score of > or =15 on the Aggression scale of the Overt Aggression Scale-Modified (OAS-M) and who fulfilled DSM-IV criteria for Cluster B personality disorder (n=96), intermittent explosive disorder (n=116), or post-traumatic stress disorder (n=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 (p <0.001). 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.",
author = "Eric Hollander and Tracy, {Katherine A.} and Swann, {Alan C.} and Coccaro, {Emil F.} and McElroy, {Susan L.} and Patricia Wozniak and Sommerville, {Kenneth W.} and Charles Nemeroff",
year = "2003",
month = "6",
day = "1",
language = "English",
volume = "28",
pages = "1186--1197",
journal = "Neuropsychopharmacology",
issn = "0893-133X",
publisher = "Nature Publishing Group",
number = "6",

}

TY - JOUR

T1 - Divalproex in the treatment of impulsive aggression

T2 - efficacy in cluster B personality disorders.

AU - Hollander, Eric

AU - Tracy, Katherine A.

AU - Swann, Alan C.

AU - Coccaro, Emil F.

AU - McElroy, Susan L.

AU - Wozniak, Patricia

AU - Sommerville, Kenneth W.

AU - Nemeroff, Charles

PY - 2003/6/1

Y1 - 2003/6/1

N2 - 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, double-blind, placebo-controlled study in which outpatients with a score of > or =15 on the Aggression scale of the Overt Aggression Scale-Modified (OAS-M) and who fulfilled DSM-IV criteria for Cluster B personality disorder (n=96), intermittent explosive disorder (n=116), or post-traumatic stress disorder (n=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 (p <0.001). 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.

AB - 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, double-blind, placebo-controlled study in which outpatients with a score of > or =15 on the Aggression scale of the Overt Aggression Scale-Modified (OAS-M) and who fulfilled DSM-IV criteria for Cluster B personality disorder (n=96), intermittent explosive disorder (n=116), or post-traumatic stress disorder (n=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 (p <0.001). 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.

UR - http://www.scopus.com/inward/record.url?scp=0042844766&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0042844766&partnerID=8YFLogxK

M3 - Article

VL - 28

SP - 1186

EP - 1197

JO - Neuropsychopharmacology

JF - Neuropsychopharmacology

SN - 0893-133X

IS - 6

ER -