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