Effect of Cognitive Behavioral Therapy in OCD Highlighted... | NCT00792038

Studies
Effect of Cognitive Behavioral Therapy in OCD Highlighted by Neuropsychological Tests and MRI: Pathophysiology and Treatment Outcome Predictors

NCT00792038

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Aug 2, 2012Estimated

Enrollment

88Actual

Phase

Not provided

Conditions

Obsessive-Compulsive Disorder

Interventions

Not provided

Countries

Denmark

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

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Nov 14, 2008

First Submission Date that Met QC Criteria

Nov 14, 2008

First Posted Date

Nov 17, 2008Estimated

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

Aug 1, 2012

Last Update Posted Date

Aug 2, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

OCD patients are assessed before and after treatment using diagnostic tools, rating scales neuropsychological assessment and functional and structural MR-scans.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		OCD patients
2		Normal Controls

Interventions

Not provided

Measure	Description	Time Frame
Y-Bocs		Before and after treatment approx 20 weeks apart

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Steady state medication 3 months prior to the study

Exclusion Criteria:

History of head trauma or other organic brain disease
Pregnancy.
Pacemaker or other ferromagnetic materials in the body.
Comorbid psychiatric illnesses assessed using SCAN- interview (30) other than moderate depression (Ham-D<17) or anxiety disorders.
Antipsychotics

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

OCD patients from the primary care clinics in middle Jutland, Denmark

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tue BH Hartmann	Aarhus University Hospital, Risskov	Principal Investigator
Sanne Kjær	Aarhus University Hospital, Risskov	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital, Risskov		Risskov		8240	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24674961	Derived	Vandborg SK, Hartmann TB, Bennedsen BE, Pedersen AD, Thomsen PH. Memory and executive functions in patients with obsessive-compulsive disorder. Cogn Behav Neurol. 2014 Mar;27(1):8-16. doi: 10.1097/WNN.0000000000000021.

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders