Obsessive-Compulsive DisorderNCT02450695
rTMS in Treatment Refractory Obsessive-Compulsive Disorder
A study testing rTMS in people with Obsessive-Compulsive Disorder, run by McMaster University at 1 site in Canada.
Trial summary
This study will evaluate the effectiveness of rTMS as a potential treatment for refractory OCD in a randomized, crossover design. 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?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to Apr 2019
- 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
- Patients with a primary diagnosis of OCD (DSM 5) according to the MINI
- Y-BOCS score of ≥20
- History of treatment-resistant OCD, established by a trained psychiatrist with extensive expertise in the OCD field. Treatment-resistance will be defined as non-response to at least two SRIs trials (clomipramine, fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram).
Who cannot join
- Any additional current psychiatric comorbidity, except for mild depressive and anxious symptoms
- A lifetime DSM-5 diagnosis of schizophrenia or other psychotic syndromes, substance dependence or substance abuse, including alcohol, bipolar I or II disorder, mental disorder due to a general medical condition
- Serious suicide risk
- Episodic OCD
- Illness duration less than two years
- Hospitalization in the last 6 months
Show all 13Show fewer
- Pharmacological treatment changes in the last 3 months
- The inability to receive rTMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives)
- Any major medical disease
- Pregnancy or nursing of an infant
- The inability or refusal to provide informed consent
- Prior TMS exposure (in order to reduce the risk of unblinding).
- No psychotherapy and/or pharmacological treatment changes will be allowed during the study period. Pharmacologically treated patients should be on constant medications for at least 2 weeks before entering the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Crossed-over Trial Examining Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in Treatment Refractory Obsessive-Compulsive Disorder.
This study will evaluate the effectiveness of rTMS as a potential treatment for refractory OCD in a randomized, crossover design.
Read the detailed description
The study is a minimum of 7 weeks long. In the first treatment phase (three weeks), participants will be randomly assigned to one of two treatment conditions: active rTMS or sham rTMS. The "sham" rTMS is the inactive form of the treatment where the experience during the sessions will be similar to an active rTMS session, but it will have no medical value. During these 3 weeks, they will attend a session each day for 5 days per week at Mood Disorders Clinic located at St. Joseph's Healthcare. Each of these sessions will be an hour long totalling 15 visits in the first 3 weeks. After every 5 sessions they will be asked to complete the following self-report questionnaires: Baratt Impulsiveness Scale, Hamilton Anxiety Rating Scale and the Hamilton Depression Rating Scale. The clinician-rated: Clinical Global Impression Scale and Yale Brown Obsessive Compulsive Scales will also be completed.
The two treatment phases will be separated by a flexible wash-out of a minimum of one week where participants will not attend any visits.
After this, they will begin the second treatment phase (three weeks) which will be the treatment condition they were not previously assigned to. In other words, individuals previously on the active rTMS treatment will now begin sham rTMS treatment and vice versa. These sessions will be identical to those involved in the first treatment phase, except the treatment condition will be different. Before and after each treatment session they will also be asked a series of questions to rate potential rTMS side effects and complete a cognitive task known as the "Go/no-go task."
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- rTMS
- Keywords
- rTMS, treatment refractory, treatment resistant, SSRI, clomipramine
- 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.
rTMSDevice
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Experimental | In rTMS, a device called a "stimulator" provides energy to a "magnetic coil". The coil is a handheld unit that delivers magnetic pulses. The coil is placed against the scalp on the top of your head. Sessions will occur once a day, 5 days/week, for 3 weeks. Receives: Device: rTMS |
| Sham rTMS | Sham comparator | The coil in the sham rTMS phase will be positioned 90 degrees off the scalp, with one wind of the coil touching the scalp. This will ensure that the participant will not be affected by the machine during this time. All other factors will be similar to the active rTMS phase. Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale
Measured: 7 Weeks
Secondary outcomes (4)
Barratt Impulsiveness Scale
Measured: 7 Weeks
Hamilton Anxiety rating Scale
Measured: 7 weeks
Hamilton Depression Rating Scale
Measured: 7 Weeks
Clinical Global Impression Scale
Measured: 7 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJul 2016
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Why it stopped: No participants were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Michael Van Ameringen, MD, FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450695
- Sponsor's protocol ID
- 0190
- Status last verified
- Jun 2019
- First submitted
- 19 May 2015
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossed-over Trial Examining Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in Treatment Refractory Obsessive-Compulsive Disorder.
- ClinicalTrials.gov ID
- NCT02450695
- Acronym / sponsor ID
- 0190
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- rTMS, treatment refractory, treatment resistant, SSRI, clomipramine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, Hamilton Health Sciences Corporation
- Study start
- Jul 2016
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 21 May 2015 (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.
This study will evaluate the effectiveness of rTMS as a potential treatment for refractory OCD in a randomized, crossover design.
Detailed description
The study is a minimum of 7 weeks long. In the first treatment phase (three weeks), participants will be randomly assigned to one of two treatment conditions: active rTMS or sham rTMS. The "sham" rTMS is the inactive form of the treatment where the experience during the sessions will be similar to an active rTMS session, but it will have no medical value. During these 3 weeks, they will attend a session each day for 5 days per week at Mood Disorders Clinic located at St. Joseph's Healthcare. Each of these sessions will be an hour long totalling 15 visits in the first 3 weeks. After every 5 sessions they will be asked to complete the following self-report questionnaires: Baratt Impulsiveness Scale, Hamilton Anxiety Rating Scale and the Hamilton Depression Rating Scale. The clinician-rated: Clinical Global Impression Scale and Yale Brown Obsessive Compulsive Scales will also be completed.
The two treatment phases will be separated by a flexible wash-out of a minimum of one week where participants will not attend any visits.
After this, they will begin the second treatment phase (three weeks) which will be the treatment condition they were not previously assigned to. In other words, individuals previously on the active rTMS treatment will now begin sham rTMS treatment and vice versa. These sessions will be identical to those involved in the first treatment phase, except the treatment condition will be different. Before and after each treatment session they will also be asked a series of questions to rate potential rTMS side effects and complete a cognitive task known as the "Go/no-go task."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: rTMSIn rTMS, a device called a "stimulator" provides energy to a "magnetic coil". The coil is a handheld unit that delivers magnetic pulses. The coil is placed against the scalp on the top of your head. Sessions will occur once a day, 5 days/week, for 3 weeks. |
| Sham rTMS | Sham comparator | Device: rTMSThe coil in the sham rTMS phase will be positioned 90 degrees off the scalp, with one wind of the coil touching the scalp. This will ensure that the participant will not be affected by the machine during this time. All other factors will be similar to the active rTMS phase. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a primary diagnosis of OCD (DSM 5) according to the MINI
- Y-BOCS score of ≥20
- History of treatment-resistant OCD, established by a trained psychiatrist with extensive expertise in the OCD field. Treatment-resistance will be defined as non-response to at least two SRIs trials (clomipramine, fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram).
Key exclusion criteria (13 listed)
- Any additional current psychiatric comorbidity, except for mild depressive and anxious symptoms
- A lifetime DSM-5 diagnosis of schizophrenia or other psychotic syndromes, substance dependence or substance abuse, including alcohol, bipolar I or II disorder, mental disorder due to a general medical condition
- Serious suicide risk
- Episodic OCD
- Illness duration less than two years
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 |
|---|---|---|
| rTMS | Device | Active rTMS, Sham rTMS |
Primary outcome
Yale Brown Obsessive Compulsive Scale
Time frame: 7 Weeks
4 secondary outcomes
Barratt Impulsiveness Scale
Time frame: 7 Weeks
Hamilton Anxiety rating Scale
Time frame: 7 weeks
Hamilton Depression Rating Scale
Time frame: 7 Weeks
Clinical Global Impression Scale
Time frame: 7 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
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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.
Michael Van Ameringen, MD, FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Obsessive-Compulsive Disorder, run by McMaster University at 1 site 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 3 inclusion and 13 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: withdrawn, as of the sponsor's last update on 18 Jun 2019. 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 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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: 7 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2019.