NCT00379626

Brief Summary

The aim of this study is to determine if Cognitive treatment and hormone treatment can change the relapse rate of sexual offenders.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

5 years

First QC Date

September 21, 2006

Last Update Submit

February 13, 2017

Conditions

Paraphilia

Keywords

ParaphiliaHormonal treatmentCognitive treatment

Outcome Measures

Primary Outcomes (1)

  • The degree of cognitive distortions after treatment

    8 months

Secondary Outcomes (3)

  • Locus of control after treatment in part one.

    8 months

  • Degree of mental health problems (SCL-90)

    8 months

  • The testosterone levels before, during and after treatment

    baseline upto 8 months

Study Arms (1)

cognitive and hormone treatment

EXPERIMENTAL

cognitive and hormone (Leuprorelin) treatment

Drug: cognitive and hormone treatment

Interventions

cognitive and hormone treatmentDRUG

cognitive and hormone (Leuprorelin) treatment

cognitive and hormone treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men sentenced for paraphilia

You may not qualify if:

  • Men above 70 years and men that does not speak english

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital. Departement for forensic psyciatry, Brøset.

Trondheim, 7040, Norway

Location

Related Publications (1)

  • 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.

    PMID: 16505878RESULT

MeSH Terms

Conditions

Paraphilic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Jim Aa Nøttestad, Dr. Philos

    St. Olavs Hospital, Departement of forensic psychiatry, Brøset

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2006

First Posted

September 22, 2006

Study Start

August 1, 2003

Primary Completion

August 1, 2008

Study Completion

August 1, 2010

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

NO(1)