Status:
TERMINATED
Efficacy of a Triptan in the Treatment of Hostility and Aggression Among Convicts With a Psychiatric Treatment Order
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
FPC De Kijvelanden, Poortugaal
Conditions:
Psychotic Disorders
Antisocial Personality Disorder
Eligibility:
MALE
18-65 years
Phase:
PHASE4
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 o...
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00282165
Start Date
November 1 2006
End Date
December 1 2012
Last Update
January 26 2015
Active Locations (1)
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1
FPC De Kijvelanden
Poortugaal, Netherlands, P.O. box 900, 3160AC Rhoon