Cognitive and Hormonal Treatment of Sex Offenders | NCT00379626

Studies
Cognitive and Hormonal Treatment of Sex Offenders

NCT00379626

Sponsor

Norwegian University of Science and Technology

Status

Terminated

Last Update Posted

Feb 14, 2017Actual

Enrollment

5Actual

Phase

Phase 1

Conditions

Paraphilia

Interventions

cognitive and hormone treatment

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

too few patients participated

Expanded Access Info

Start Date

Aug 2003Actual

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2010Actual

First Submitted Date

Sep 21, 2006

First Submission Date that Met QC Criteria

Sep 21, 2006

First Posted Date

Sep 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2017

Last Update Posted Date

Feb 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cognitive and hormone treatment	Experimental	cognitive and hormone (Leuprorelin) treatment	Drug: cognitive and hormone treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cognitive and hormone treatment	Drug	cognitive and hormone (Leuprorelin) treatment	cognitive and hormone treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The degree of cognitive distortions after treatment		8 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men sentenced for paraphilia

Exclusion Criteria:

Men above 70 years and men that does not speak english

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jim Aa Nøttestad, Dr. Philos	St. Olavs Hospital, Departement of forensic psychiatry, Brøset	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Olavs Hospital. Departement for forensic psyciatry, Brøset.		Trondheim		7040	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16505878	Result	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.