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

NCT00282165 | Terminated Phase 4

• 1 other identifier: 05/187-E
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• number of aggressive incidents

  10 weeks

• aggression scores

  10 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

four week double blind placebo treatment phase

Drug: placebo

naratriptan

ACTIVE COMPARATOR

four week double blind experimental treatment using daily naratriptan tablets

Drug: naratriptan

Interventions

naratriptan DRUG

four weeks double blind experimental treatment using oral naratriptan

naratriptan

placebo DRUG

four weeks double blind placebo treatment

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient under psychiatric treatment order for violent crime
• Patient is undergoing psychiatric treatment
• Informed consent

You may not qualify if:

• Unable for informed consent
• Intolerance for any prescription compound
• Severe liver failure (Child-Pugh grade c) of renal failure (creatinine clearance \< 15 ml/min.)
• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• FPC De Kijvelanden, Poortugaal: collaborator

Study Sites (1)

FPC De Kijvelanden

Poortugaal, P.O. box 900, 3160AC Rhoon, Netherlands

Location

MeSH Terms

Conditions

Psychotic Disorders; Antisocial Personality Disorder; Disruptive, Impulse Control, and Conduct Disorders

Interventions

naratriptan

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Personality Disorders

Study Officials

• Frank Koerselman, MD, PhD

  UMC Utrecht

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Adriano van der Loo, MD

  FPC De Kijvelanden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD psychiatrist

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

NL (1)