Efficacy of a Triptan in the Treatment of Hostility and Aggression Among Convicts With a Psychiatric Treatment Order
Recruitment status was Recruiting
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.
Antisocial Personality Disorder
Impulse Regulation Disorder
Intermittent Explosive Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
|Official Title:||Efficacy of a Triptan in the Treatment of Hostility and Aggression Among Convicts With a Psychiatric Treatment Order|
- number of aggressive incidents [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
- aggression scores [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo
four week double blind placebo treatment phase
four weeks double blind placebo treatment
Active Comparator: naratriptan
four week double blind experimental treatment using daily naratriptan tablets
four weeks double blind experimental treatment using oral naratriptan
Hide Detailed Description
EFFICACY OF A TRIPTAN IN THE TREATMENT OF HOSTILITY AND AGGRESSION AMONG CONVICTS WITH A PSYCHIATRIC TREATMENT ORDER
Adriano van der Loo*, Dr. Rob van Ojen**, Prof. dr. Frank Koerselman**, Prof. Dr. Henk Nijman*, Prof. Dr. Berend Olivier***
*Forensic Psychiatric Center De Kijvelanden, Poortugaal; **University Medical Center and Rudolf Magnus Institute of Neuroscience Utrecht; ***Department of Pharmacy, Utrecht University
In a large number of studies, hostility, impulsivity and aggression have been demonstrated to be associated with decreased activity of the serotonergic system (Nelson and Chiavegatto 2001). In rodents a specific role for the serotonin-1b receptor has been reported (Olivier et al. 1995) and it has been shown that specific central serotonin-1b/d agonists such as lipophilic triptans have a specific anti-aggressive effect. To date, no studies have been conducted on treatment of hostility, impulsivity or aggression among humans using a triptan.
Goal of the Study
Aim is to establish the efficacy of naratriptan, registered for the treatment of migraine, as an anti-aggressive agent in patients with refractory disorders of impulse control due to psychosis or psychopathy.
Primary question is whether or not violent behavior and aggressive incidents decrease when naratriptan is administered daily in addition to treatment as usual.
Secondary questions are:
- Does overall prognosis of the underlying condition improve with the intervention?
- Can responders be differentiated from non-responders in terms of covariants including endocrine factors and polymorphisms in areas in the genome that are involved in serotonergic neurotransmission?
- Is the triptan well tolerated in this group and in this dose-range?
The sample consists of male adult volunteers with a psychiatric disorder who have been convicted and sentenced to undergo psychiatric treatment in Forensic Psychiatric Hospital "De Kijvelanden" after having committed a violent crime and have in the previous year been involved in violent incidents at least three times in spite of comprehensive psychiatric treatment of the underlying disorder.
Intervention /Drug /Dosage
In the course of a four-week period either a naratriptan 2.5 mg. tablet or a placebo tablet will be added twice to the daily medication in a double blind randomized fashion. Subsequently, after a two-week washout, patients will cross-over towards the alternative treatment condition for another four-week period.
Outcome will be measured using the AVL (aggression questionnaire) and the SDAS (social dysfunction and aggression scale) after 2, 4, 6, 8, and 10 weeks of treatment. Change on the CGI (Clinical Global Impression) will be compared to baseline. As usual at the study-site, the SOAS-R (Staff Observation Aggression Scale) will be filled in in case of violent incidents and type, number and duration of restraining interventions will be registered. Also recorded will be symptoms occurring during treatment and number and cause of dropout.
Description and Estimate of Risk and Burden for Participants
Safety and tolerability of both naratriptan and placebo are very well documented. Incidence and nature of side-effects and interactions has been described to be low and relatively mild, also with frequent (daily) use of naratriptan. Patients at risk for side-effects will be excluded from the study. Drugs will be added to the usual medication of the participants. A questionnaire will be administered and blood will be collected upon inclusion in the study. Data including genotype will be processed anonymously.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282165
|Contact: Robert L van Ojen, MD, PhD||0031-302507109||R.L.vanOjen@umcutrecht.nl|
|FPC De Kijvelanden||Recruiting|
|Poortugaal, Netherlands, P.O. box 900, 3160AC Rhoon|
|Contact: Adriano van der Loo, MD 0031-105031224 Adriano.firstname.lastname@example.org|
|Principal Investigator: Adriano van der Loo, MD|
|Study Chair:||Frank Koerselman, MD, PhD||UMC Utrecht|
|Study Director:||Rob L. van Ojen, MD, PhD||UMC Utrecht|
|Study Director:||Henk Nijman, PhD||FPC De Kijvelanden, Poortugaal|
|Study Director:||Berend Olivier, PhD||Utrecht University, Dep. of Pharmacy|
|Principal Investigator:||Adriano van der Loo, MD||FPC De Kijvelanden|