Obsessive Compulsive DisorderNCT00616486
rTMS in Treatment of Obsessive Compulsive Disorder (OCD)
A study testing repetitive transcranial magnetic stimulation in people with Obsessive Compulsive Disorder, run by Queen's University at 3 sites in 3 countries.
Trial summary
Low frequency (1Hz) rTMS applied bilaterally and simultaneously over SMA for 6 weeks in addition to the standard treatment regimen for OCD, will lead to significant improvement in patients' symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2008to Nov 2012
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed patient informed consent;
- primary obsessive compulsive disorder;
- YBOCS score at least 20;
- males/females 18-65yrs;
- treated with adequate dose of SSRI at least 8 weeks at some stage of illness;
- currently using adequate, stable dose of SSRI at least 4 weeks but not responding.
Who cannot join
- schizophrenia, other psychotic disorders, bipolar I, current major depressive disorder (HDRS(17)>18, substance/alcohol dependence within last 6 months;
- severe axis II;
- suicidal score>=6 on MINI;
- metallic implant in cranium;
- severe/unstable medical conditions;
- not responding to ECT or had TMS in last 6 months;
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- history epilepsy;
- neurological disorder leading to increased intracranial pressure;
- severe cardiac disorder/intracardiac lines, pacemakers;
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Canada1 site
Providence Care, Mental Health Services
Kingston, Ontario, K7L 4X3
About this study
Official title: A Multicentre, Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy, Safety, and Clinical Outcomes of Low Frequency, Repetitive Transcranial Magnetic Stimulation (Over Supplementary Motor Area (SMA) Applied Bilaterally and Simultaneously) Versus Sham (Placebo rTMS) Treatment for 6 Weeks, When Added to a Stable Pharmacotherapy in Subjects With Obsessive Compulsive Disorder (OCD).
Low frequency (1Hz) rTMS applied bilaterally and simultaneously over SMA for 6 weeks in addition to the standard treatment regimen for OCD, will lead to significant improvement in patients' symptoms. The clinical improvement detected by YBOCS, CGI and SF-36 QOLS scores will be statistically significant in active treatment group compared to sham (placebo) treatment group.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- repetitive transcranial magnetic stimulation, sham (placebo)
- 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.
repetitive transcranial magnetic stimulationDevice
Also called rTMS machine (MagPro, Medtronic)
6 weeks of stimulation with RMT frequency 1Hz, intensity 110% of RMT for 20 minutes, 5 minutes of trains with 2 minutes of intra-train intervals to both SMA. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6.
sham (placebo)Device
Also called rTMS machine (MagPro, Medtronic).
Sham treatment will mimic active treatment mentioned above.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: repetitive transcranial magnetic stimulation |
| 2 | Placebo comparator | Not described Receives: Device: sham (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Measured: pre, week 1, 2, 4, 6, 8, 12
Secondary outcomes (6)
Clinical Global Impression
Measured: pre, week 1, 2, 4, 6, 8, 12
Hamilton Depression Rating Scale-21(HDRS)
Measured: pre, week 1, 2, 4, 6, 8, 12
Pittsburgh Sleep Quality Index (PSQI)
Measured: pre, week 1, 2, 4, 6, 8, 12
Hamilton Anxiety Rating Scale (HARS)
Measured: pre, week 1, 2, 4, 6, 8, 12
SF-36 QOLS version (1)
Measured: pre, week 1, 2, 4, 6, 8, 12
Visual Analogue Scale
Measured: pre, week 1, 2, 4, 6, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2010
- Study completionNov 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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Military Medical Academy, Bulgaria, Dokuz Eylul University
- Responsible party
- Principal investigator, Dr. Roumen Milev, Queen's University
- Investigators
- Roumen Milev, MD, Study chair, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616486
- Sponsor's protocol ID
- psiy-266-07
- Status last verified
- Dec 2015
- First submitted
- 4 Feb 2008
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hawken ER, Dilkov D, Kaludiev E, Simek S, Zhang F, Milev R. Transcranial Magnetic Stimulation of the Supplementary Motor Area in the Treatment of Obsessive-Compulsive Disorder: A Multi-Site Study. Int J Mol Sci. 2016 Mar 22;17(3):420. doi: 10.3390/ijms17030420.
PubMed 27011177
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy, Safety, and Clinical Outcomes of Low Frequency, Repetitive Transcranial Magnetic Stimulation (Over Supplementary Motor Area (SMA) Applied Bilaterally and Simultaneously) Versus Sham (Placebo rTMS) Treatment for 6 Weeks, When Added to a Stable Pharmacotherapy in Subjects With Obsessive Compulsive Disorder (OCD).
- ClinicalTrials.gov ID
- NCT00616486
- Acronym / sponsor ID
- psiy-266-07
- Conditions
- Obsessive Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Military Medical Academy, Bulgaria, Dokuz Eylul University
- Study start
- Jan 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Feb 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.
Low frequency (1Hz) rTMS applied bilaterally and simultaneously over SMA for 6 weeks in addition to the standard treatment regimen for OCD, will lead to significant improvement in patients' symptoms. The clinical improvement detected by YBOCS, CGI and SF-36 QOLS scores will be statistically significant in active treatment group compared to sham (placebo) treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: repetitive transcranial magnetic stimulation |
| 2 | Placebo comparator | Device: sham (placebo) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- signed patient informed consent;
- primary obsessive compulsive disorder;
- YBOCS score at least 20;
- males/females 18-65yrs;
- treated with adequate dose of SSRI at least 8 weeks at some stage of illness;
Key exclusion criteria (9 listed)
- schizophrenia, other psychotic disorders, bipolar I, current major depressive disorder (HDRS(17)>18, substance/alcohol dependence within last 6 months;
- severe axis II;
- suicidal score>=6 on MINI;
- metallic implant in cranium;
- severe/unstable medical conditions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulationAlso: rTMS machine (MagPro, Medtronic)6 weeks of stimulation with RMT frequency 1Hz, intensity 110% of RMT for 20 minutes, 5 minutes of trains with 2 minutes of intra-train intervals to both SMA. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6. | Device | 1 |
| sham (placebo)Also: rTMS machine (MagPro, Medtronic).Sham treatment will mimic active treatment mentioned above. | Device | 2 |
Primary outcome
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time frame: pre, week 1, 2, 4, 6, 8, 12
6 secondary outcomes
Clinical Global Impression
Time frame: pre, week 1, 2, 4, 6, 8, 12
Hamilton Depression Rating Scale-21(HDRS)
Time frame: pre, week 1, 2, 4, 6, 8, 12
Pittsburgh Sleep Quality Index (PSQI)
Time frame: pre, week 1, 2, 4, 6, 8, 12
Hamilton Anxiety Rating Scale (HARS)
Time frame: pre, week 1, 2, 4, 6, 8, 12
SF-36 QOLS version (1)
Time frame: pre, week 1, 2, 4, 6, 8, 12
Visual Analogue Scale
Time frame: pre, week 1, 2, 4, 6, 8, 12
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 16 Dec 2015.
- Derived from this study: PubMed 27011177Hawken ER, Dilkov D, Kaludiev E, Simek S, Zhang F, Milev R. Transcranial Magnetic Stimulation of the Supplementary Motor Area in the Treatment of Obsessive-Compulsive Disorder: A Multi-Site Study. Int J Mol Sci. 2016 Mar 22;17(3):420. doi: 10.3390/ijms17030420.
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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.
Roumen Milev, MD study chair
Queen's University
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation in people with Obsessive Compulsive Disorder, run by Queen's University at 3 sites in 3 countries.
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 6 inclusion and 9 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 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bulgaria, Canada, Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Yale-Brown Obsessive Compulsive Scale (YBOCS) (time frame: pre, week 1, 2, 4, 6, 8, 12). 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 NCT00616486, 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 16 Dec 2015.