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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by UMC Utrecht.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
FPC De Kijvelanden, Poortugaal
Information provided by (Responsible Party):
R.L. van Ojen, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00282165
First received: January 24, 2006
Last updated: September 12, 2011
Last verified: July 2010
  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 4

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:


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

  Hide Detailed Description

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-1b/d 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 2.5 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Disease
Personality Disorders
Psychotic Disorders
Mental Disorders
Aggression
Impulse Control Disorders
Antisocial Personality Disorder
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms
Naratriptan
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014