Obsessive Compulsive DisorderNCT00396552
Treating Refractory Obsessive Compulsive Disorder With rTMS
A study testing refractory transcranial magnetic stimulation (rTMS) in people with Obsessive Compulsive Disorder, run by Centre for Addiction and Mental Health at 2 sites in Canada.
Trial summary
Obsessive-compulsive disorder (OCD) is a severe psychiatric condition with only limited response to current first-line treatments, comprising pharmacotherapy and cognitive-behavioural therapy. 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?
- refractory transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2006to Dec 2011
- 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
- voluntary and competent to consent based on their ability to provide a spontaneous narrative description of the key elements of the study
- have a Structured Clinical Interview for DSM-IV (SCID) confirmed diagnosis of OCD
- are between the ages of 18 and 65
- have failed to achieve a clinical response, or did not tolerate, at least 3 separate antidepressant trials of sufficient dose for at least 10 weeks
- have a score of greater than or equal to 17 on the Y-BOCS. A careful medical and neurological history will be taken to ensure that subjects have no unstable conditions that would preclude them from entering into the study. This history will focus on conditions such as seizures, stroke, hypertension, diabetes, coronary artery disease, thyroid problems, respiratory illness, allergies and presence of metal implants
Who cannot join
- have a history of DSM-IV substance dependence in the last 6 months, and have DSM-IV substance abuse in the last month
- have a concomitant major unstable medical or neurologic illness or have had a history of seizures
- acutely suicidal
- are pregnant
- have metal implants. With respect to concomitant medications, patients will be excluded if they are currently (or in the last 4 weeks) taking: (a) more than lorazepam 2 mg daily (or equivalent), (b) monoamine oxidase inhibitors, (c) and/or bupropion due to its associated increased risk for seizures.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
About this study
Official title: Treating Refractory Obsessive Compulsive Disorder With Repetitive Transcranial Magnetic Stimulation: A Double-blind Sham Controlled Longitudinal Study
Obsessive-compulsive disorder (OCD) is a severe psychiatric condition with only limited response to current first-line treatments, comprising pharmacotherapy and cognitive-behavioural therapy. Repetitive transcranial magnetic stimulation (rTMS) is a relatively new technique which has shown great promise in the treatment of refractory mood disorders, and schizophrenia, by alteration of brain activity. Previous work has demonstrated altered cortical excitability in OCD and preliminary studies have suggested that rTMS may have therapeutic potential in OCD. This pilot study will investigate the effectiveness of rTMS for treatment-refractory OCD, and establish appropriate treatment parameters. In addition, mechanisms whereby rTMS exerts its therapeutic effect will be explored using TMS to evaluate cortical inhibition and measures of cognitive biases and processing.
Read the detailed description
Obsessive-compulsive disorder (OCD) is a severe and debilitating psychiatric illness characterized by intrusive unwanted thoughts (obsessions) and repetitive or ritualistic actions intended to reduce anxiety (compulsions). OCD is common with lifetime prevalence estimated at 2.5%, equally affecting both genders and all ethnic groups. It is also typically chronic in nature, resulting in substantial impact on quality of life. Functioning can be markedly impaired; it has been estimated that 20% of individuals with OCD should be considered severely affected. Although the pathophysiology is unclear, hyperactivity in the prefrontal orbital cortex has been consistently demonstrated, and normalizes with treatment. A decrease in cortical inhibition has been implicated in OCD utilizing a variety of methods, including paired-pulse TMS.
First-line treatment typically consists of either cognitive-behavioural therapy and/or pharmacotherapy with serotonin reuptake inhibitors (SSRI's or clomipramine). Ordinarily only modest benefits are obtained with conventional pharmacotherapy, with the majority of patients considered nonresponsive or only partially responsive. The limited success of conventional treatment makes identifying alternative treatments a priority. Although psychosurgery is regarded as a valid alternative for severe and refractory individuals, the potential for serious and irreversible adverse consequences is significant, rendering this a treatment of 'last resort' only. Repetitive TMS appears to represent a safe and effective alternative for severe sufferers.
Repetitive TMS has been shown to be an effective therapeutic tool for the treatment of several neuropsychiatric disorders including MDD and schizophrenia, but investigations into its utility in OCD are very preliminary. In a study of 12 OCD patients single session stimulation of the right lateral prefrontal cortex (20 Hz, 80% motor threshold, for 20 minutes) resulted in a decrease in compulsive urges for eight hours in contrast to the left prefrontal cortex which was associated with more modest response . Sachdev et al randomly assigned 12 individuals to receive right or left dorsolateral prefrontal stimulation (10 Hz,110% resting motor threshold, 15 minutes 5 sessions/week for 2 weeks). Subjects showed significant improvement at two weeks and 1-month follow-up, regardless of lateralit. A randomized controlled trial comparing right prefrontal stimulation to sham treatment in 18 OCD subjects was negative, however low frequency (1 Hz) stimulation was used in contrast to previous reports (110% motor threshold, 20 minutes 3 times/week for 6 weeks). Most recently a small study of 10 individuals with OCD and/or Tourette's syndrome found benefit with low-frequency stimulation of the supplementary motor area (1 Hz, 100% motor threshold, 20 minutes 5 sessions/week for 2 weeks). Notably subjects were treatment-resistant in both this and the Sachdev study. Thus although this limited literature precludes any definitive conclusions, it suggests that rTMS may be of benefit in refractory OCD.
In this study we propose to investigate the effectiveness of rTMS treatment in refractory OCD. Although ideal treatment parameters need to be established, the above literature suggests that high frequency stimulation of the dorsolateral prefrontal cortex is likely to be beneficial. Bilateral stimulation will be used; our previous work has demonstrated this method to be safe and well tolerated. Moreover patients will be assigned in randomized double-blind fashion to receive either active or sham TMS, allowing for more definitive conclusions to be drawn. We also propose to explore whether the induction of CI mediates the therapeutic effects of rTMS on OCD symptoms.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- refractory transcranial magnetic stimulation (rTMS), Sham condition
- Keywords
- refractory transcranial magnetic stimulation, obsessive compulsive disorder, randomized, placebo-controlled, double-blind
- 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.
refractory transcranial magnetic stimulation (rTMS)Device
Bilateral rTMS will be delivered according to the following protocol: high frequency left (HFL) stimulation will initially be applied at 20 Hz, in 25 trains of 1.5 second duration with a 30 second interval between trains and at 100% of the RMT for a total of 25 minutes of stimulation. Following this HFR stimulation will be applied at the same parameters. Therefore a total of 50 minutes of stimulation will be delivered.
Sham conditionDevice
Sham stimulation will be made at the site of active treatment but with only the side edge resting on the scalp. It will be administered as HFL and HFR for 50 minutes but with the coil angled 45-90 degrees away from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those with active stimulation but with minimal direct brain effects. Participants will be unable to see the stimulating coil and therefore will remain blind to the treatment condition.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: refractory transcranial magnetic stimulation (rTMS) |
| 2 | Sham comparator | Not described Receives: Device: Sham condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of change on the Yale-Brown Obsessive Compulsive Disorder Scale
Measured: intermittent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peggy Richter, Centre for Addiction and Mental Health
- Investigators
- Margaret A Richter, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396552
- Sponsor's protocol ID
- 100/2006
- Status last verified
- Feb 2013
- First submitted
- 6 Nov 2006
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fitzgerald PB, Benitez J, de Castella A, Daskalakis ZJ, Brown TL, Kulkarni J. A randomized, controlled trial of sequential bilateral repetitive transcranial magnetic stimulation for treatment-resistant depression. Am J Psychiatry. 2006 Jan;163(1):88-94. doi: 10.1176/appi.ajp.163.1.88.
PubMed 16390894Loo CK, Mitchell PB. A review of the efficacy of transcranial magnetic stimulation (TMS) treatment for depression, and current and future strategies to optimize efficacy. J Affect Disord. 2005 Nov;88(3):255-67. doi: 10.1016/j.jad.2005.08.001. Epub 2005 Sep 2.
PubMed 16139895Klein E, Kolsky Y, Puyerovsky M, Koren D, Chistyakov A, Feinsod M. Right prefrontal slow repetitive transcranial magnetic stimulation in schizophrenia: a double-blind sham-controlled pilot study. Biol Psychiatry. 1999 Nov 15;46(10):1451-4. doi: 10.1016/s0006-3223(99)00182-1.
PubMed 10578460Hoffman RE, Hawkins KA, Gueorguieva R, Boutros NN, Rachid F, Carroll K, Krystal JH. Transcranial magnetic stimulation of left temporoparietal cortex and medication-resistant auditory hallucinations. Arch Gen Psychiatry. 2003 Jan;60(1):49-56. doi: 10.1001/archpsyc.60.1.49.
PubMed 12511172Greenberg BD, Ziemann U, Cora-Locatelli G, Harmon A, Murphy DL, Keel JC, Wassermann EM. Altered cortical excitability in obsessive-compulsive disorder. Neurology. 2000 Jan 11;54(1):142-7. doi: 10.1212/wnl.54.1.142.
PubMed 10636140Mantovani A, Lisanby SH, Pieraccini F, Ulivelli M, Castrogiovanni P, Rossi S. Repetitive transcranial magnetic stimulation (rTMS) in the treatment of obsessive-compulsive disorder (OCD) and Tourette's syndrome (TS). Int J Neuropsychopharmacol. 2006 Feb;9(1):95-100. doi: 10.1017/S1461145705005729. Epub 2005 Jun 28.
PubMed 15982444Sachdev PS, McBride R, Loo CK, Mitchell PB, Malhi GS, Croker VM. Right versus left prefrontal transcranial magnetic stimulation for obsessive-compulsive disorder: a preliminary investigation. J Clin Psychiatry. 2001 Dec;62(12):981-4. doi: 10.4088/jcp.v62n1211.
PubMed 11780880Horwath E, Weissman MM. The epidemiology and cross-national presentation of obsessive-compulsive disorder. Psychiatr Clin North Am. 2000 Sep;23(3):493-507. doi: 10.1016/s0193-953x(05)70176-3.
PubMed 10986723
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Refractory Obsessive Compulsive Disorder With Repetitive Transcranial Magnetic Stimulation: A Double-blind Sham Controlled Longitudinal Study
- ClinicalTrials.gov ID
- NCT00396552
- Acronym / sponsor ID
- 100/2006
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- refractory transcranial magnetic stimulation, obsessive compulsive disorder, randomized, placebo-controlled, double-blind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Nov 2006 (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.
Obsessive-compulsive disorder (OCD) is a severe psychiatric condition with only limited response to current first-line treatments, comprising pharmacotherapy and cognitive-behavioural therapy. Repetitive transcranial magnetic stimulation (rTMS) is a relatively new technique which has shown great promise in the treatment of refractory mood disorders, and schizophrenia, by alteration of brain activity. Previous work has demonstrated altered cortical excitability in OCD and preliminary studies have suggested that rTMS may have therapeutic potential in OCD. This pilot study will investigate the effectiveness of rTMS for treatment-refractory OCD, and establish appropriate treatment parameters. In addition, mechanisms whereby rTMS exerts its therapeutic effect will be explored using TMS to evaluate cortical inhibition and measures of cognitive biases and processing.
Detailed description
Obsessive-compulsive disorder (OCD) is a severe and debilitating psychiatric illness characterized by intrusive unwanted thoughts (obsessions) and repetitive or ritualistic actions intended to reduce anxiety (compulsions). OCD is common with lifetime prevalence estimated at 2.5%, equally affecting both genders and all ethnic groups. It is also typically chronic in nature, resulting in substantial impact on quality of life. Functioning can be markedly impaired; it has been estimated that 20% of individuals with OCD should be considered severely affected. Although the pathophysiology is unclear, hyperactivity in the prefrontal orbital cortex has been consistently demonstrated, and normalizes with treatment. A decrease in cortical inhibition has been implicated in OCD utilizing a variety of methods, including paired-pulse TMS.
First-line treatment typically consists of either cognitive-behavioural therapy and/or pharmacotherapy with serotonin reuptake inhibitors (SSRI's or clomipramine). Ordinarily only modest benefits are obtained with conventional pharmacotherapy, with the majority of patients considered nonresponsive or only partially responsive. The limited success of conventional treatment makes identifying alternative treatments a priority. Although psychosurgery is regarded as a valid alternative for severe and refractory individuals, the potential for serious and irreversible adverse consequences is significant, rendering this a treatment of 'last resort' only. Repetitive TMS appears to represent a safe and effective alternative for severe sufferers.
Repetitive TMS has been shown to be an effective therapeutic tool for the treatment of several neuropsychiatric disorders including MDD and schizophrenia, but investigations into its utility in OCD are very preliminary. In a study of 12 OCD patients single session stimulation of the right lateral prefrontal cortex (20 Hz, 80% motor threshold, for 20 minutes) resulted in a decrease in compulsive urges for eight hours in contrast to the left prefrontal cortex which was associated with more modest response . Sachdev et al randomly assigned 12 individuals to receive right or left dorsolateral prefrontal stimulation (10 Hz,110% resting motor threshold, 15 minutes 5 sessions/week for 2 weeks). Subjects showed significant improvement at two weeks and 1-month follow-up, regardless of lateralit. A randomized controlled trial comparing right prefrontal stimulation to sham treatment in 18 OCD subjects was negative, however low frequency (1 Hz) stimulation was used in contrast to previous reports (110% motor threshold, 20 minutes 3 times/week for 6 weeks). Most recently a small study of 10 individuals with OCD and/or Tourette's syndrome found benefit with low-frequency stimulation of the supplementary motor area (1 Hz, 100% motor threshold, 20 minutes 5 sessions/week for 2 weeks). Notably subjects were treatment-resistant in both this and the Sachdev study. Thus although this limited literature precludes any definitive conclusions, it suggests that rTMS may be of benefit in refractory OCD.
In this study we propose to investigate the effectiveness of rTMS treatment in refractory OCD. Although ideal treatment parameters need to be established, the above literature suggests that high frequency stimulation of the dorsolateral prefrontal cortex is likely to be beneficial. Bilateral stimulation will be used; our previous work has demonstrated this method to be safe and well tolerated. Moreover patients will be assigned in randomized double-blind fashion to receive either active or sham TMS, allowing for more definitive conclusions to be drawn. We also propose to explore whether the induction of CI mediates the therapeutic effects of rTMS on OCD symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: refractory transcranial magnetic stimulation (rTMS) |
| 2 | Sham comparator | Device: Sham condition |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- voluntary and competent to consent based on their ability to provide a spontaneous narrative description of the key elements of the study
- have a Structured Clinical Interview for DSM-IV (SCID) confirmed diagnosis of OCD
- are between the ages of 18 and 65
- have failed to achieve a clinical response, or did not tolerate, at least 3 separate antidepressant trials of sufficient dose for at least 10 weeks
- have a score of greater than or equal to 17 on the Y-BOCS. A careful medical and neurological history will be taken to ensure that subjects have no unstable conditions that would preclude them from entering into the study. This history will focus on conditions such as seizures, stroke, hypertension, diabetes, coronary artery disease, thyroid problems, respiratory illness, allergies and presence of metal implants
Key exclusion criteria (5 listed)
- have a history of DSM-IV substance dependence in the last 6 months, and have DSM-IV substance abuse in the last month
- have a concomitant major unstable medical or neurologic illness or have had a history of seizures
- acutely suicidal
- are pregnant
- have metal implants. With respect to concomitant medications, patients will be excluded if they are currently (or in the last 4 weeks) taking: (a) more than lorazepam 2 mg daily (or equivalent), (b) monoamine oxidase inhibitors, (c) and/or bupropion due to its associated increased risk for seizures.
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 |
|---|---|---|
| refractory transcranial magnetic stimulation (rTMS)Bilateral rTMS will be delivered according to the following protocol: high frequency left (HFL) stimulation will initially be applied at 20 Hz, in 25 trains of 1.5 second duration with a 30 second interval between trains and at 100% of the RMT for a total of 25 minutes of stimulation. Following this HFR stimulation will be applied at the same parameters. Therefore a total of 50 minutes of stimulation will be delivered. | Device | 1 |
| Sham conditionSham stimulation will be made at the site of active treatment but with only the side edge resting on the scalp. It will be administered as HFL and HFR for 50 minutes but with the coil angled 45-90 degrees away from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those with active stimulation but with minimal direct brain effects. Participants will be unable to see the stimulating coil and therefore will remain blind to the treatment condition. | Device | 2 |
Primary outcome
Degree of change on the Yale-Brown Obsessive Compulsive Disorder Scale
Time frame: intermittent
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 15 Feb 2013.
- Background: PubMed 16390894Fitzgerald PB, Benitez J, de Castella A, Daskalakis ZJ, Brown TL, Kulkarni J. A randomized, controlled trial of sequential bilateral repetitive transcranial magnetic stimulation for treatment-resistant depression. Am J Psychiatry. 2006 Jan;163(1):88-94. doi: 10.1176/appi.ajp.163.1.88.
- Background: PubMed 16139895Loo CK, Mitchell PB. A review of the efficacy of transcranial magnetic stimulation (TMS) treatment for depression, and current and future strategies to optimize efficacy. J Affect Disord. 2005 Nov;88(3):255-67. doi: 10.1016/j.jad.2005.08.001. Epub 2005 Sep 2.
- Background: PubMed 10578460Klein E, Kolsky Y, Puyerovsky M, Koren D, Chistyakov A, Feinsod M. Right prefrontal slow repetitive transcranial magnetic stimulation in schizophrenia: a double-blind sham-controlled pilot study. Biol Psychiatry. 1999 Nov 15;46(10):1451-4. doi: 10.1016/s0006-3223(99)00182-1.
- Background: PubMed 12511172Hoffman RE, Hawkins KA, Gueorguieva R, Boutros NN, Rachid F, Carroll K, Krystal JH. Transcranial magnetic stimulation of left temporoparietal cortex and medication-resistant auditory hallucinations. Arch Gen Psychiatry. 2003 Jan;60(1):49-56. doi: 10.1001/archpsyc.60.1.49.
- Background: PubMed 10636140Greenberg BD, Ziemann U, Cora-Locatelli G, Harmon A, Murphy DL, Keel JC, Wassermann EM. Altered cortical excitability in obsessive-compulsive disorder. Neurology. 2000 Jan 11;54(1):142-7. doi: 10.1212/wnl.54.1.142.
- Background: PubMed 15982444Mantovani A, Lisanby SH, Pieraccini F, Ulivelli M, Castrogiovanni P, Rossi S. Repetitive transcranial magnetic stimulation (rTMS) in the treatment of obsessive-compulsive disorder (OCD) and Tourette's syndrome (TS). Int J Neuropsychopharmacol. 2006 Feb;9(1):95-100. doi: 10.1017/S1461145705005729. Epub 2005 Jun 28.
- Background: PubMed 11780880Sachdev PS, McBride R, Loo CK, Mitchell PB, Malhi GS, Croker VM. Right versus left prefrontal transcranial magnetic stimulation for obsessive-compulsive disorder: a preliminary investigation. J Clin Psychiatry. 2001 Dec;62(12):981-4. doi: 10.4088/jcp.v62n1211.
- Background: PubMed 10986723Horwath E, Weissman MM. The epidemiology and cross-national presentation of obsessive-compulsive disorder. Psychiatr Clin North Am. 2000 Sep;23(3):493-507. doi: 10.1016/s0193-953x(05)70176-3.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
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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.
Margaret A Richter, MD principal investigator
Sunnybrook Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing refractory transcranial magnetic stimulation (rTMS) in people with Obsessive Compulsive Disorder, run by Centre for Addiction and Mental Health at 2 sites in Canada.
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 5 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 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Degree of change on the Yale-Brown Obsessive Compulsive Disorder Scale (time frame: intermittent). 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 NCT00396552, which also lists 8 linked publications.
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 15 Feb 2013.