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

This study is currently recruiting participants.

Verified July 2010 by UMC Utrecht

First Received on January 24, 2006. Last Updated on September 12, 2011 History of Changes

Sponsor:	UMC Utrecht
Collaborator:	FPC De Kijvelanden, Poortugaal
Information provided by (Responsible Party):	R.L. van Ojen, UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00282165

Purpose

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.

Condition	Intervention	Phase
Psychotic Disorders Antisocial Personality Disorder Impulse Regulation Disorder Intermittent Explosive Disorder	Drug: naratriptan Drug: placebo	Phase IV

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Personality Disorders Psychotic Disorders

Drug Information available for: Naratriptan Naratriptan hydrochloride

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:

number of aggressive incidents [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
aggression scores [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
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)

Arms	Assigned Interventions
Placebo Comparator: placebo four week double blind placebo treatment phase	Drug: placebo four weeks double blind placebo treatment
Active Comparator: naratriptan four week double blind experimental treatment using daily naratriptan tablets	Drug: naratriptan four weeks double blind experimental treatment using oral naratriptan

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282165

Contacts

Contact: Robert L van Ojen, MD, PhD

0031-302507109

R.L.vanOjen@umcutrecht.nl

Locations

Netherlands
FPC De Kijvelanden	Recruiting
Poortugaal, Netherlands, P.O. box 900, 3160AC Rhoon
Contact: Adriano van der Loo, MD 0031-105031224 Adriano.van.der.loo@kijvelanden.nl
Principal Investigator: Adriano van der Loo, MD

Sponsors and Collaborators

UMC Utrecht

FPC De Kijvelanden, Poortugaal

Investigators

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

More Information

No publications provided

Responsible Party:	R.L. van Ojen, MD PhD psychiatrist, UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00282165 History of Changes
Other Study ID Numbers:	05/187-E
Study First Received:	January 24, 2006
Last Updated:	September 12, 2011
Health Authority:	Netherlands: Independent Ethics Committee; Netherlands: Ministry of Health, Welfare and Sport; Netherlands: Justice Department

Additional relevant MeSH terms:

Aggression
Antisocial Personality Disorder
Impulse Control Disorders
Personality Disorders
Psychotic Disorders
Mental Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Naratriptan
Serotonin 5-HT1 Receptor Agonists

Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012