Major Depressive DisorderNCT04785456
rTMS for Suicidality in Opioid Use Disorder
A study testing Active TBS in people with Major Depressive Disorder and Opioid-use Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
This trial is a randomized, double blind, controlled pilot study that will compare bilateral theta burst stimulation (TBS) and sham treatment for patients with opioid use disorder (OUD) and Major Depressive Disorder (MDD) experiencing suicidality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Opioid-use Disorder
- What is being tested?
- Active TBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2022to 1 Mar 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of providing informed consent and research procedures according to the brain stimulation attending psychiatrist
- Between the ages of 18-60 years
- Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Opioid Dependence and MDD.
- On a stable treatment regimen without any change in opioid agonist or antidepressant medications or dosages in the last 30 days. Participants will be asked not to change their medication regimen for the duration of the study.
- Baseline score of >/=4 on the scale for suicidal ideation (SSI).
Who cannot join
- Currently pregnant or intending to be pregnant during the duration of the study
- Bipolar disorder, any psychotic disorder or current psychotic symptoms
- Previous rTMS treatment
- Known active seizure disorder, significant head injury with an imaging verified lesion
- Unstable medical illness
- Presence of cardiac pacemaker, intracranial implant, or metal in the cranium
- Participants taking > 2 mg lorazepam (or a benzodiazepine at an equivalent dose) or taking any anticonvulsant medication during treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repetitive Transcranial Magnetic Stimulation for Suicidality in Opioid Use Disorders
This trial is a randomized, double blind, controlled pilot study that will compare bilateral theta burst stimulation (TBS) and sham treatment for patients with opioid use disorder (OUD) and Major Depressive Disorder (MDD) experiencing suicidality.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) is used therapeutically in major depressive disorder resistant to standard treatments, and recently also shown to be effective in reducing suicidality with a bilateral approach. Recently, a new form of rTMS has been developed called theta burst stimulation (TBS) which requires a much shorter daily treatment duration and has been found to be non-inferior to standard rTMS. The investigators propose to conduct a randomized controlled clinical trial of a daily, 20 session course of bilateral TBS versus sham stimulation in the treatment of suicidality in patients with OUD and MDD. The investigators will explore whether TBS can have other clinical effects on decreasing symptoms of MDD, craving for opioids, and rates of relapse to opioid use. The investigators will also examine whether rTMS can engage GABA mediated inhibition using combined transcranial magnetic stimulation and electroencephalography (TMS-EEG) will be assessed before and after intervention. Clinical outcomes measured before, during, at end of treatment, and 4-weeks post treatment.
- Conditions
- Major Depressive Disorder, Opioid-use Disorder
- Being tested
- Active TBS, Sham TBS
- Keywords
- Suicidality, rTMS
- Medical subject headings
- Depressive Disorder, Major, Opioid-Related Disorders, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active TBSDevice
MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)
Sham TBSDevice
MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)
| Study group | Role | What they receive |
|---|---|---|
| Active TBS | Experimental | Daily, 4-week, 5-days per week treatment sessions, each consisting of:
First, intermittent TBS (iTBS) over the L-DLPFC: triplet 50 Hz bursts, repeated at 5 Hz, 2 s on and 8 s off, (600 pulses per session, total duration of 3 min 9 s), then continuous TBS (cTBS) over the R-DLPFC as 40 s uninterrupted bursts (600 pulses). Intensity at 120% resting motor threshold (RMT). Receives: Device: Active TBS |
| Sham TBS | Sham comparator | Daily, 4-week, 5-days per week treatment sessions. The sham coil will generate auditory and somatosensory (vibratory) stimuli identical to the active stimulation. Receives: Device: Sham TBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Scale for Suicidal Ideation Remission
A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome.
Measured: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Secondary outcomes (5)
Change in Scale for Suicidal Ideation Change
A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome.
Measured: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Change in Columbia - Suicide Severity Rating Scale Change
An interviewer-rated suicide risk assessment tool. Min value = 0, Max value = N/A. Higher score = worse outcome
Measured: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
17-item Hamilton Rating Scale for Depression (HRSD-17) Change
A rating scale for measuring severity of depressive symptoms. Min value = 0 Max value = 52. Higher score = worse outcome
Measured: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Visual Analogue Scale for Opioid Cravings Change
A rating scale for subjective cravings to use opioids. Min value = 0 Max value = 100. Higher score = worse outcome.
Measured: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Timeline Followback Change
Self-reported substance use over a designated period of time. Min value = 0 Max value = N/A. Higher score = worse outcome.
Measured: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Mar 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
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 Major Depressive 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Daphne Voineskos, MD, PhD, Principal investigator, Clinician Scientist, Psychiatrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785456
- Sponsor's protocol ID
- 131/2020
- Status last verified
- Mar 2024
- First submitted
- 12 Feb 2021
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tang VM, Le Foll B, Daskalakis ZJ, Wang AL, Buckley L, Blumberger DM, Voineskos D. Repetitive transcranial magnetic stimulation for the treatment of suicidality in opioid use disorder: a pilot feasibility randomized controlled trial. Eur Psychiatry. 2025 Mar 5;68(1):e63. doi: 10.1192/j.eurpsy.2025.28.
PubMed 40040511
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation for Suicidality in Opioid Use Disorders
- ClinicalTrials.gov ID
- NCT04785456
- Acronym / sponsor ID
- 131/2020
- Conditions
- Major Depressive Disorder, Opioid-use Disorder
- Keywords
- Suicidality, rTMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 8 Mar 2021 (actual)
- 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 trial is a randomized, double blind, controlled pilot study that will compare bilateral theta burst stimulation (TBS) and sham treatment for patients with opioid use disorder (OUD) and Major Depressive Disorder (MDD) experiencing suicidality.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) is used therapeutically in major depressive disorder resistant to standard treatments, and recently also shown to be effective in reducing suicidality with a bilateral approach. Recently, a new form of rTMS has been developed called theta burst stimulation (TBS) which requires a much shorter daily treatment duration and has been found to be non-inferior to standard rTMS. The investigators propose to conduct a randomized controlled clinical trial of a daily, 20 session course of bilateral TBS versus sham stimulation in the treatment of suicidality in patients with OUD and MDD. The investigators will explore whether TBS can have other clinical effects on decreasing symptoms of MDD, craving for opioids, and rates of relapse to opioid use. The investigators will also examine whether rTMS can engage GABA mediated inhibition using combined transcranial magnetic stimulation and electroencephalography (TMS-EEG) will be assessed before and after intervention. Clinical outcomes measured before, during, at end of treatment, and 4-weeks post treatment.
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 |
|---|---|---|
| Active TBS | Experimental | Device: Active TBSDaily, 4-week, 5-days per week treatment sessions, each consisting of: First, intermittent TBS (iTBS) over the L-DLPFC: triplet 50 Hz bursts, repeated at 5 Hz, 2 s on and 8 s off, (600 pulses per session, total duration of 3 min 9 s), then continuous TBS (cTBS) over the R-DLPFC as 40 s uninterrupted bursts (600 pulses). Intensity at 120% resting motor threshold (RMT). |
| Sham TBS | Sham comparator | Device: Sham TBSDaily, 4-week, 5-days per week treatment sessions. The sham coil will generate auditory and somatosensory (vibratory) stimuli identical to the active stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Capable of providing informed consent and research procedures according to the brain stimulation attending psychiatrist
- Between the ages of 18-60 years
- Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Opioid Dependence and MDD.
- On a stable treatment regimen without any change in opioid agonist or antidepressant medications or dosages in the last 30 days. Participants will be asked not to change their medication regimen for the duration of the study.
- Baseline score of >/=4 on the scale for suicidal ideation (SSI).
Key exclusion criteria (7 listed)
- Currently pregnant or intending to be pregnant during the duration of the study
- Bipolar disorder, any psychotic disorder or current psychotic symptoms
- Previous rTMS treatment
- Known active seizure disorder, significant head injury with an imaging verified lesion
- Unstable medical illness
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 |
|---|---|---|
| Active TBSMagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark) | Device | Active TBS |
| Sham TBSMagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark) | Device | Sham TBS |
Primary outcome
Change in Scale for Suicidal Ideation Remission
Time frame: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome.
5 secondary outcomes
Change in Scale for Suicidal Ideation Change
Time frame: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Change in Columbia - Suicide Severity Rating Scale Change
Time frame: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
17-item Hamilton Rating Scale for Depression (HRSD-17) Change
Time frame: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Visual Analogue Scale for Opioid Cravings Change
Time frame: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Timeline Followback Change
Time frame: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
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 5 Mar 2024.
- Derived from this study: PubMed 40040511Tang VM, Le Foll B, Daskalakis ZJ, Wang AL, Buckley L, Blumberger DM, Voineskos D. Repetitive transcranial magnetic stimulation for the treatment of suicidality in opioid use disorder: a pilot feasibility randomized controlled trial. Eur Psychiatry. 2025 Mar 5;68(1):e63. doi: 10.1192/j.eurpsy.2025.28.
- Individual participant dataSharing planned: Undecided
Related trials for Major Depressive Disorder
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
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.
Daphne Voineskos, MD, PhD principal investigator
Clinician Scientist, Psychiatrist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active TBS in people with Major Depressive Disorder and Opioid-use Disorder, run by Centre for Addiction and Mental Health 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 5 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 5 Mar 2024. 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 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?
Change in Scale for Suicidal Ideation Remission (time frame: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up). 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 NCT04785456, 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 5 Mar 2024.