Towards an individualized treatment of patients with disorders of aggression regulation; endophenotypes of aggressive behavior.

Completed

• Conditions: aggression regulation disorder; Intermittent Explosive Disorder; 10034726

• Registration Number: NL-OMON38824
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 154

Inclusion Criteria

- Age 18-55 years
- Men and women
- Outpatient
- Meeting DSM-IV criteria for antisocial personality disorder, borderline personality disorder or the integrated research criteria for Intermittent Explosive Disorder (IED-IR):
- Recurrent incidents of aggression manifest as either;
Verbal or physical aggression towards other people, animals, or property occurring twice weekly
on average for one month, or
- Three episodes involving physical assault against other people or destruction of property over one-year period
- The degree of aggressiveness expressed is grossly out of proportion to the provocation or any precipitating psychosocial stressors
- The aggressive behavior is generally not premeditated (e.g., is impulsive) and is not committed in order to achieve some tangible objective (e.g., money, power, intimidation, etc.)
- The aggressive behavior causes either marked distress in the individual or impairment in occupational or interpersonal functioning
- The aggressive behavior is not better accounted for by another mental disorder (e.g., Major Depressive/Manic/Psychotic Disorder; ADHD); General Medical Condition (e.g., Head Trauma, Senile Dementia Alzheimer*s Type); or to the direct physiological effects of a substance
- Score on Overt Aggression Scale-Modified for Outpatient Use (MOAS) of >= 15 and/or a score of >= 5 on the Social Dysfunction Aggression Scale (SDAS)

Exclusion Criteria

- Lifetime history of (hypo)mania, schizophrenia, or delusional disorder
- Current major depression
- Current alcohol or substance dependence
- Starting or changing pharmacotherapy relating to aggressive behavior

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome of aggressive behavior will be the score on the Modified Overt<br /><br>Aggression Scale for Outpatient Use (MOAS) and the Social Dysfunction and<br /><br>Aggression Scale (SDAS), which will be completed by the patient, and the<br /><br>Clinical Global Impression Scale for severity (CGI-s). Efficacy measures will<br /><br>be assessed at baseline, 6 and 12 weeks. A decrease of aggression of 50% on the<br /><br>MOAS and/or SDAS will be considered as a response to treatment, a decrease<br /><br>between 20% and 50% as a partial response and a decrease of less than 20% will<br /><br>be considered as a non response.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.v.t.</p><br>