Obsessive-Compulsive DisorderNCT00792038
Effect of Cognitive Behavioral Therapy in OCD Highlighted by Neuropsychological Tests and MRI: Pathophysiology and Treatment Outcome Predictors
An observational study of Obsessive-Compulsive Disorder, run by University of Aarhus at 1 site in Denmark.
Trial summary
OCD patients are assessed before and after treatment using diagnostic tools, rating scales neuropsychological assessment and functional and structural MR-scans. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- How many people
- 88 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Jul 2012
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: OCD patients from the primary care clinics in middle Jutland, Denmark
Who may be able to join
- 1. Steady state medication 3 months prior to the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
OCD patients are assessed before and after treatment using diagnostic tools, rating scales neuropsychological assessment and functional and structural MR-scans.
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Psychological tests, Magnetic Resonance Imaging, Cognitive therapy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | OCD patients | |
| 2 | Normal Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Y-Bocs
Measured: Before and after treatment approx 20 weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionJul 2012
- Study completionJul 2012
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 Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tue BH Hartmann, Principal investigator, Aarhus University Hospital, RisskovSanne Kjær, Study director, Aarhus University Hospital, Risskov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792038
- Sponsor's protocol ID
- M-20080161
- Status last verified
- Aug 2012
- First submitted
- 14 Nov 2008
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24674961
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive Behavioral Therapy in OCD Highlighted by Neuropsychological Tests and MRI: Pathophysiology and Treatment Outcome Predictors
- ClinicalTrials.gov ID
- NCT00792038
- Acronym / sponsor ID
- M-20080161
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Psychological tests, Magnetic Resonance Imaging, Cognitive therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 17 Nov 2008 (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.
OCD patients are assessed before and after treatment using diagnostic tools, rating scales neuropsychological assessment and functional and structural MR-scans.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –OCD patients |
| 2 | – | –Normal Controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- OCD patients from the primary care clinics in middle Jutland, Denmark
Key inclusion criteria (1 listed)
- 1. Steady state medication 3 months prior to the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Y-Bocs
Time frame: Before and after treatment approx 20 weeks apart
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- Derived from this study: PubMed 24674961Vandborg 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.
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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.
Tue BH Hartmann principal investigator
Aarhus University Hospital, Risskov
Sanne Kjær study director
Aarhus University Hospital, Risskov
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-Compulsive Disorder, run by University of Aarhus at 1 site in Denmark.
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 5 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: finished, as of the sponsor's last update on 2 Aug 2012. 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 Denmark. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Y-Bocs (time frame: Before and after treatment approx 20 weeks apart). 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 NCT00792038, 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 2 Aug 2012.