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

NCT00282165 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2015-01-26

No results posted yet for this study

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.

Conditions

  • Psychotic Disorders
  • Antisocial Personality Disorder
  • Impulse Regulation Disorder
  • Intermittent Explosive Disorder

Interventions

DRUG

naratriptan

four weeks double blind experimental treatment using oral naratriptan

DRUG

placebo

four weeks double blind placebo treatment

Sponsors & Collaborators

  • FPC De Kijvelanden, Poortugaal

    collaborator UNKNOWN

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Frank Koerselman, MD, PhD · UMC Utrecht

  • Rob L. van Ojen, MD, PhD · UMC Utrecht

  • Henk Nijman, PhD · FPC De Kijvelanden, Poortugaal

  • Berend Olivier, PhD · Utrecht University, Dep. of Pharmacy

  • Adriano van der Loo, MD · FPC De Kijvelanden

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00282165 on ClinicalTrials.gov