Obsessive-Compulsive DisorderPhase 2NCT01043900
Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant OCD
A Phase 2 study testing repetitive transcranial magnetic stimulation (rTMS) in people with Obsessive-Compulsive Disorder, run by University of Sao Paulo General Hospital.
Trial summary
OCD is a chronic condition with a high rate of poor responders to conventional treatments, such as antidepressants and psychotherapy. Chronic symptoms can lead to important social impairment and suffering for patients and families. 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 (rTMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Aug 2009
- Phase
- Phase 2
- 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
- resistant OCD patients: maximum 25% reduction in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores after at least 3 adequate trials with serotonin reuptake inhibitors (SRI) (including clomipramine) and 20 hours of cognitive behavioral therapy (CBT) or documented intolerance to either treatment.
Who cannot join
- metallic cerebral implants
- history of severe trauma or brain injury
- organic brain disease
- severe somatic disease
- history of drug dependence
- chronic psychosis
- present manic state
About this study
Official title: Right Prefrontal High Frequency rTMS in Treatment of Resistant OCD: a Double Blind, Randomized Controlled Trial
OCD is a chronic condition with a high rate of poor responders to conventional treatments, such as antidepressants and psychotherapy. Chronic symptoms can lead to important social impairment and suffering for patients and families.
The present study aims to investigate if the addition of transcranial magnetic stimulation can provide enhanced response to conventional treatment.
Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.
Read the detailed description
The treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 6 consecutive weeks. Each session lasts up to 30 minutes.
Side effects include scalp discomfort and mild headache. No anesthesia is required.
Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results. The present technique has never been employed in previous studies, but risks are insignificant
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- Obsessive-Compulsive Disorder, rTMS, Transcranial Magnetic Stimulation, treatment, randomized controlled trials
- 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 stimulation (rTMS)Procedure or surgery
Also called TMS
30 daily sessions: each with 40 trains of 5 seconds at 10Hz, with a 25 second inter-train interval, at an intensity of 110% of motor threshold. Site: Right Dorsolateral Prefrontal Cortex
| Study group | Role | What they receive |
|---|---|---|
| Sham rTMS | Placebo comparator | Patients with stable medication regimen receiving 30 daily sessions of PLACEBO rTMS delivered to the right dorsolateral prefrontal cortex Receives: Procedure: repetitive transcranial magnetic stimulation (rTMS) |
| Active rTMS | Active comparator | Patients with stable medication regimen receiving 30 daily sessions of active rTMS delivered to the right dorsolateral prefrontal cortex Receives: Procedure: repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A reduction of at least 30 % in the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores and an "improved" or "much improved" score on the Clinical Global Impression (CGI) improvement scale by the end of follow-up
Measured: 3 - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startAug 2003
- Primary completionAug 2009
- Study completionAug 2009
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 Sao Paulo General HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Carlos G Mansur, MD, Principal investigator, Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043900
- Sponsor's protocol ID
- cgmansur01
- Status last verified
- Sep 2009
- First submitted
- 5 Jan 2010
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Mansur CG, Myczkowki ML, de Barros Cabral S, Sartorelli Mdo C, Bellini BB, Dias AM, Bernik MA, Marcolin MA. Placebo effect after prefrontal magnetic stimulation in the treatment of resistant obsessive-compulsive disorder: a randomized controlled trial. Int J Neuropsychopharmacol. 2011 Nov;14(10):1389-97. doi: 10.1017/S1461145711000575. Epub 2011 Apr 18.
PubMed 21557884
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Prefrontal High Frequency rTMS in Treatment of Resistant OCD: a Double Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01043900
- Acronym / sponsor ID
- cgmansur01
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, rTMS, Transcranial Magnetic Stimulation, treatment, randomized controlled trials
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 7 Jan 2010 (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 is a chronic condition with a high rate of poor responders to conventional treatments, such as antidepressants and psychotherapy. Chronic symptoms can lead to important social impairment and suffering for patients and families.
The present study aims to investigate if the addition of transcranial magnetic stimulation can provide enhanced response to conventional treatment.
Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.
Detailed description
The treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 6 consecutive weeks. Each session lasts up to 30 minutes.
Side effects include scalp discomfort and mild headache. No anesthesia is required.
Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results. The present technique has never been employed in previous studies, but risks are insignificant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham rTMS | Placebo comparator | Procedure: repetitive transcranial magnetic stimulation (rTMS)Patients with stable medication regimen receiving 30 daily sessions of PLACEBO rTMS delivered to the right dorsolateral prefrontal cortex |
| Active rTMS | Active comparator | Procedure: repetitive transcranial magnetic stimulation (rTMS)Patients with stable medication regimen receiving 30 daily sessions of active rTMS delivered to the right dorsolateral prefrontal cortex |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- resistant OCD patients: maximum 25% reduction in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores after at least 3 adequate trials with serotonin reuptake inhibitors (SRI) (including clomipramine) and 20 hours of cognitive behavioral therapy (CBT) or documented intolerance to either treatment.
Key exclusion criteria (7 listed)
- metallic cerebral implants
- history of severe trauma or brain injury
- organic brain disease
- severe somatic disease
- history of drug dependence
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 stimulation (rTMS)Also: TMS30 daily sessions: each with 40 trains of 5 seconds at 10Hz, with a 25 second inter-train interval, at an intensity of 110% of motor threshold. Site: Right Dorsolateral Prefrontal Cortex | Procedure or surgery | Active rTMS, Sham rTMS |
Primary outcome
A reduction of at least 30 % in the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores and an "improved" or "much improved" score on the Clinical Global Impression (CGI) improvement scale by the end of follow-up
Time frame: 3 - 6 months
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 7 Jan 2010.
- Derived from this study: PubMed 21557884Mansur CG, Myczkowki ML, de Barros Cabral S, Sartorelli Mdo C, Bellini BB, Dias AM, Bernik MA, Marcolin MA. Placebo effect after prefrontal magnetic stimulation in the treatment of resistant obsessive-compulsive disorder: a randomized controlled trial. Int J Neuropsychopharmacol. 2011 Nov;14(10):1389-97. doi: 10.1017/S1461145711000575. Epub 2011 Apr 18.
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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.
Carlos G Mansur, MD principal investigator
Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing repetitive transcranial magnetic stimulation (rTMS) in people with Obsessive-Compulsive Disorder, run by University of Sao Paulo General Hospital.
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 7 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 7 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
A reduction of at least 30 % in the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores and an "improved" or "much improved" score on the Clinical Global Impression (CGI) improvement scale by the end of follow-up (time frame: 3 - 6 months). 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 NCT01043900, 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 7 Jan 2010.