ParaphiliaPhase 1NCT00379626
Cognitive and Hormonal Treatment of Sex Offenders
A Phase 1 study testing cognitive and hormone treatment in people with Paraphilia, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of this study is to determine if Cognitive treatment and hormone treatment can change the relapse rate of sexual offenders. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Paraphilia
- What is being tested?
- cognitive and hormone treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2003to Aug 2010
- Phase
- Phase 1
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men sentenced for paraphilia
Who cannot join
- Men above 70 years and men that does not speak english
Trial locations and contacts
1 site in 1 country.
Norway1 site
St. Olavs Hospital. Departement for forensic psyciatry, Brøset.
Trondheim, 7040
About this study
Official title: Cognitive Group and Hormonal Treatment of Sex Offenders.
The aim of this study is to determine if Cognitive treatment and hormone treatment can change the relapse rate of sexual offenders.
Read the detailed description
The aim of this study is to determine if Cognitive treatment and hormone treatment can change the relapse rate of sexual offenders.
In the first part of study we are studying changes in the offenders cognitive distortions and in the second part we are studying changes in sexual activities and sexual thoughts after treatment with Leuprorelin. The study is an open pre and post study.
- Conditions
- Paraphilia
- Being tested
- cognitive and hormone treatment
- Keywords
- Paraphilia, Hormonal treatment, Cognitive treatment
- Medical subject headings
- Paraphilic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive and hormone treatmentDrug
cognitive and hormone (Leuprorelin) treatment
| Study group | Role | What they receive |
|---|---|---|
| cognitive and hormone treatment | Experimental | cognitive and hormone (Leuprorelin) treatment Receives: Drug: cognitive and hormone treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of cognitive distortions after treatment
Measured: 8 months
Secondary outcomes (3)
Locus of control after treatment in part one.
Measured: 8 months
Degree of mental health problems (SCL-90)
Measured: 8 months
The testosterone levels before, during and after treatment
measured each 3rd month
Measured: baseline upto 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2006 (estimated)
- Study startAug 2003
- Primary completionAug 2008
- Study completionAug 2010
Why it stopped: too few patients participated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParaphiliaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jim Aa Nøttestad, Dr. Philos, Principal investigator, St. Olavs Hospital, Departement of forensic psychiatry, Brøset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379626
- Sponsor's protocol ID
- AH 048-01
- Status last verified
- Feb 2017
- First submitted
- 21 Sep 2006
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Nottestad JA, Bjarnar E, Lundmo PI, Sandvik M. [Treatment of sex offenders with leuprorelin]. Tidsskr Nor Laegeforen. 2006 Feb 23;126(5):633-4. No abstract available. Norwegian.
PubMed 16505878
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Group and Hormonal Treatment of Sex Offenders.
- ClinicalTrials.gov ID
- NCT00379626
- Acronym / sponsor ID
- AH 048-01
- Conditions
- Paraphilia
- Keywords
- Paraphilia, Hormonal treatment, Cognitive treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: too few patients participated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2003 (actual)
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Sep 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.
The aim of this study is to determine if Cognitive treatment and hormone treatment can change the relapse rate of sexual offenders.
Detailed description
The aim of this study is to determine if Cognitive treatment and hormone treatment can change the relapse rate of sexual offenders.
In the first part of study we are studying changes in the offenders cognitive distortions and in the second part we are studying changes in sexual activities and sexual thoughts after treatment with Leuprorelin. The study is an open pre and post study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive and hormone treatment | Experimental | Drug: cognitive and hormone treatmentcognitive and hormone (Leuprorelin) treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men sentenced for paraphilia
Key exclusion criteria (1 listed)
- Men above 70 years and men that does not speak english
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 |
|---|---|---|
| cognitive and hormone treatmentcognitive and hormone (Leuprorelin) treatment | Drug | cognitive and hormone treatment |
Primary outcome
The degree of cognitive distortions after treatment
Time frame: 8 months
3 secondary outcomes
Locus of control after treatment in part one.
Time frame: 8 months
Degree of mental health problems (SCL-90)
Time frame: 8 months
The testosterone levels before, during and after treatment
Time frame: baseline upto 8 months
Results and safety
The study was stopped early (reason given: too few patients participated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Results publication: PubMed 16505878Nottestad JA, Bjarnar E, Lundmo PI, Sandvik M. [Treatment of sex offenders with leuprorelin]. Tidsskr Nor Laegeforen. 2006 Feb 23;126(5):633-4. No abstract available. Norwegian.
Related trials for Paraphilia
Recruiting
A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders.
Partner
RecruitingObservational study
Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study
Paraphilic Disorders, Sexual Addiction
Recruiting
Psychological Treatment for Paraphilic Disorders
Paraphilic Disorders
Not yet recruitingObservational study
"Evolution of Sexual Symptoms in Paraphilic Sexual Offenders With/Without Antiandrogen or SSRI Treatment"
Sexual Disorder, Physiological
Recruiting
Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
Pedophilia, Hebephilia
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.
Jim Aa Nøttestad, Dr. Philos principal investigator
St. Olavs Hospital, Departement of forensic psychiatry, Brøset
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cognitive and hormone treatment in people with Paraphilia, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 1 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 14 Feb 2017. 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 Norway. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: too few patients participated). 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?
The degree of cognitive distortions after treatment (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00379626, which also lists 1 linked publication.
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 14 Feb 2017.