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

This study has been terminated.
(Required number of subjects to be included could not be accomplished)
FPC De Kijvelanden, Poortugaal
Information provided by (Responsible Party):
R.L. van Ojen, UMC Utrecht Identifier:
First received: January 24, 2006
Last updated: January 23, 2015
Last verified: January 2015
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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]
  • aggression scores [ Time Frame: 10 weeks ]

Enrollment: 8
Study Start Date: November 2006
Study Completion Date: December 2012
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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00282165

FPC De Kijvelanden
Poortugaal, Netherlands, P.O. box 900, 3160AC Rhoon
Sponsors and Collaborators
UMC Utrecht
FPC De Kijvelanden, Poortugaal
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

Responsible Party: R.L. van Ojen, MD PhD psychiatrist, UMC Utrecht Identifier: NCT00282165     History of Changes
Other Study ID Numbers: 05/187-E
Study First Received: January 24, 2006
Last Updated: January 23, 2015

Additional relevant MeSH terms:
Personality Disorders
Psychotic Disorders
Mental Disorders
Disruptive, Impulse Control, and Conduct Disorders
Antisocial Personality Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Behavioral Symptoms
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 28, 2017