Psychotic DisordersPhase 4NCT00282165
Efficacy of a Triptan in the Treatment of Hostility and Aggression Among Convicts With a Psychiatric Treatment Order
A Phase 4 study testing naratriptan in people with Psychotic Disorders and Antisocial Personality Disorder, run by UMC Utrecht at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Psychotic Disorders, Antisocial Personality Disorder, Impulse Regulation Disorder
- What is being tested?
- naratriptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2006to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
FPC De Kijvelanden
Poortugaal, P.O. box 900, 3160AC Rhoon
About this study
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.
Read the 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.
- Conditions
- Psychotic Disorders, Antisocial Personality Disorder, Impulse Regulation Disorder, Intermittent Explosive Disorder
- Being tested
- naratriptan, placebo
- Medical subject headings
- Psychotic Disorders, Antisocial Personality Disorder, Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naratriptanDrug
four weeks double blind experimental treatment using oral naratriptan
placeboDrug
four weeks double blind placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | four week double blind placebo treatment phase Receives: Drug: placebo |
| naratriptan | Active comparator | four week double blind experimental treatment using daily naratriptan tablets Receives: Drug: naratriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of aggressive incidents
Measured: 10 weeks
aggression scores
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Required number of subjects to be included could not be accomplished
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- FPC De Kijvelanden, Poortugaal
- Responsible party
- Principal investigator, R.L. van Ojen, UMC Utrecht
- Investigators
- Frank Koerselman, MD, PhD, Study chair, UMC UtrechtRob L. van Ojen, MD, PhD, Study director, UMC UtrechtHenk Nijman, PhD, Study director, FPC De Kijvelanden, PoortugaalBerend Olivier, PhD, Study director, Utrecht University, Dep. of PharmacyAdriano van der Loo, MD, Principal investigator, FPC De Kijvelanden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282165
- Sponsor's protocol ID
- 05/187-E
- Status last verified
- Jan 2015
- First submitted
- 24 Jan 2006
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Triptan in the Treatment of Hostility and Aggression Among Convicts With a Psychiatric Treatment Order
- ClinicalTrials.gov ID
- NCT00282165
- Acronym / sponsor ID
- 05/187-E
- Conditions
- Psychotic Disorders, Antisocial Personality Disorder, Impulse Regulation Disorder, Intermittent Explosive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Required number of subjects to be included could not be accomplished
- Enrolment
- 8 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- FPC De Kijvelanden, Poortugaal
- Study start
- Nov 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebofour week double blind placebo treatment phase |
| naratriptan | Active comparator | Drug: naratriptanfour week double blind experimental treatment using daily naratriptan tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naratriptanfour weeks double blind experimental treatment using oral naratriptan | Drug | naratriptan |
| placebofour weeks double blind placebo treatment | Drug | placebo |
Primary outcome
number of aggressive incidents
Time frame: 10 weeks
aggression scores
Time frame: 10 weeks
Results and safety
The study was stopped early (reason given: Required number of subjects to be included could not be accomplished). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Koerselman, MD, PhD study chair
UMC Utrecht
Rob L. van Ojen, MD, PhD study director
UMC Utrecht
Henk Nijman, PhD study director
FPC De Kijvelanden, Poortugaal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing naratriptan in people with Psychotic Disorders and Antisocial Personality Disorder, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Required number of subjects to be included could not be accomplished). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of aggressive incidents (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.