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Cognitive and Hormonal Treatment of Sex Offenders

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ClinicalTrials.gov Identifier: NCT00379626
Recruitment Status : Terminated (too few patients participated)
First Posted : September 22, 2006
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Paraphilia Drug: cognitive and hormone treatment Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Group and Hormonal Treatment of Sex Offenders.
Actual Study Start Date : August 2003
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arm Intervention/treatment
Experimental: cognitive and hormone treatment
cognitive and hormone (Leuprorelin) treatment
Drug: cognitive and hormone treatment
cognitive and hormone (Leuprorelin) treatment



Primary Outcome Measures :
  1. The degree of cognitive distortions after treatment [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Locus of control after treatment in part one. [ Time Frame: 8 months ]
  2. Degree of mental health problems (SCL-90) [ Time Frame: 8 months ]
  3. The testosterone levels before, during and after treatment [ Time Frame: baseline upto 8 months ]
    measured each 3rd month



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Men sentenced for paraphilia

Exclusion Criteria:

Men above 70 years and men that does not speak english


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379626


Locations
Norway
St. Olavs Hospital. Departement for forensic psyciatry, Brøset.
Trondheim, Norway, 7040
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Jim Aa Nøttestad, Dr. Philos St. Olavs Hospital, Departement of forensic psychiatry, Brøset

Publications of Results:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00379626     History of Changes
Other Study ID Numbers: AH 048-01
First Posted: September 22, 2006    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Norwegian University of Science and Technology:
Paraphilia
Hormonal treatment
Cognitive treatment

Additional relevant MeSH terms:
Paraphilic Disorders
Mental Disorders
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs