Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282165
Status:
TERMINATED
Last Update Posted:
2015-01-26
First Post:
2006-01-24
Brief Title:
Efficacy of a Triptan in the Treatment of Hostility and Aggression Among Convicts With a Psychiatric Treatment Order
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Efficacy of a Triptan in the Treatment of Hostility and Aggression Among Convicts With a Psychiatric Treatment Order
Status:
TERMINATED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Required number of subjects to be included could not be accomplished
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Background
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-1bd 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
Study Design
Population
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 25 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
Endpoints
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
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
Background
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-1bd 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
Study Design
Population
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 25 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
Endpoints
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None