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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00282165
Recruitment Status : Terminated (Required number of subjects to be included could not be accomplished)
First Posted : January 25, 2006
Last Update Posted : January 26, 2015
FPC De Kijvelanden, Poortugaal
Information provided by (Responsible Party):
R.L. van Ojen, UMC Utrecht

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 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 or disease Intervention/treatment Phase
Psychotic Disorders Antisocial Personality Disorder Impulse Regulation Disorder Intermittent Explosive Disorder Drug: naratriptan Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Efficacy of a Triptan in the Treatment of Hostility and Aggression Among Convicts With a Psychiatric Treatment Order
Study Start Date : November 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Naratriptan

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. number of aggressive incidents [ Time Frame: 10 weeks ]
  2. aggression scores [ Time Frame: 10 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00282165

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FPC De Kijvelanden
Poortugaal, Netherlands, P.O. box 900, 3160AC Rhoon
Sponsors and Collaborators
UMC Utrecht
FPC De Kijvelanden, Poortugaal
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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
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Responsible Party: R.L. van Ojen, MD PhD psychiatrist, UMC Utrecht Identifier: NCT00282165    
Other Study ID Numbers: 05/187-E
First Posted: January 25, 2006    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Personality 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