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

Towards an individualized treatment of patients with disorders of aggression regulation; endophenotypes of aggressive behavior. - Endophenotypes of Aggressive Behavior

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38824

Enrollment

154

Registered

2013-05-10

Start date

2013-06-17

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aggression regulation disorder Intermittent Explosive Disorder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
n.v.t.	—

Countries

Netherlands

Outcome results