Efficacy of a Triptan in the Treatment of Hostility and Aggression Among Convicts With a Psychiatric Treatment Order

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborator: FPC De Kijvelanden, Poortugaal
• Treatments: Naratriptan

Criteria

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.