Psychotic Disorders | Efficacy of a Triptan in the Treatment of Hostility and Aggression Among Convicts With a Psychiatric Treatment Order
Psychotic Disorders research study
What is the primary objective of this study?
In a double blind randomized clinical trial with cross-over design, treatment using naratriptan will be compared to placebo within a group of 30 convicts with psychiatric disorders such as psychosis or psychopathy with repeated aggressive outbursts resistant to conventional psychopharmacologic and other psychotherapeutic treatment. Hypothesis is that addition of naratriptan to the individual treatment regime reduces aggression -and improves general outcome- as compared to addition of placebo and is well tolerated in this group and under these conditions.
Who is eligible to participate?
Inclusion Criteria: - Patient under psychiatric treatment order for violent crime - More than two violent incidents in the year preceding inclusion, of which at least one within the last three months - Patient is undergoing psychiatric treatment - Informed consent Exclusion Criteria: - Unable for informed consent - Intolerance for any prescription compound - Severe liver failure (Child-Pugh grade c) of renal failure (creatinine clearance < 15 ml/min.) - Increased risk of coronary vasospasm: symptoms of vascular disorder (including angina pectoris), history of vascular incidents, severe HBP, ECG-abnormalities in history or at screening prior to inclusion, vascular of cardial souffles. - History of vascular incidents, hyperlipidaemia, severe HBP, DM - Use of vasoconstrictive agents such as ergotamine derivates including methysergide, or other triptans. - Increased risk of serotonergic syndrome: use of irreversible MAO-blocker - Age < 18 yr. or > 65 yr.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Antisocial Personality Disorder
Impulse Regulation Disorder
Intermittent Explosive Disorder
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:naratriptanfour weeks double blind experimental treatment using oral naratriptan
Drug:placebofour weeks double blind placebo treatment
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
placebofour week double blind placebo treatment phase
naratriptanfour week double blind experimental treatment using daily naratriptan tablets
Start Date: November 2006
Completed Date: December 2012
Phase: Phase 4
Primary Outcome: number of aggressive incidents
Study sponsors, principal investigator, and references
Principal Investigator: Frank Koerselman, MD, PhD
Lead Sponsor: UMC Utrecht
Collaborator: FPC De Kijvelanden, Poortugaal