Major Depressive DisorderPhase 2/3NCT02125799
Accelerated rTMS for Treatment-Resistant Major Depression
A Phase 2/3 study testing Accelerated HF-rTMS (Magstim Rapid 2 stimulator) in people with Major Depressive Disorder, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial summary
High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has shown safety and efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Accelerated HF-rTMS (Magstim Rapid 2 stimulator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Dec 2013
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after ≥ 2 adequate antidepressant trial(s) in the current episode;
- Baseline score ≥ 13 on the QIDS-C
- Stable medication regimen (>= 4 weeks) prior to study enrolment
Who cannot join
- Psychotic features in the current episode
- Lifetime history of psychotic disorders and/or bipolar I or II disorders
- Substance or alcohol abuse/dependence in the past 6 months
- Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
- Uncontrolled medical disease (e.g., cardiovascular, renal)
- Pregnancy and/or lactation
- Presence of a specific contraindication for rTMS (e.g., personal history of epilepsy, metallic head implant)
- Hearing loss
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Montreal, Quebec, H4H1R3
About this study
Official title: A Pilot Trial on the Effectiveness and Tolerability of Accelerated High Frequency Repetitive Transcranial Magnetic Stimulation for Treating Resistant Major Depression
High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has shown safety and efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks. Accelerated HF-TMS (aHF-rTMS), in which all treatments are delivered in less time, would have significant advantages in terms of access, patient acceptance and costs. In the present open label trial the investigators intend to assess the effectiveness and acceptability of a novel aHF-rTMS protocol (i.e., 2 daily sessions over 2 consecutive weeks; 6,000 pulses per day). For this, depressed outpatients will receive the aHF-rTMS protocol and will be assessed at baseline and at weeks 3 and 9 with several clinician- and patient- reported measures as well as with computerized neurocognitive tests.
- Conditions
- Major Depressive Disorder
- Being tested
- Accelerated HF-rTMS (Magstim Rapid 2 stimulator)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated HF-rTMS (Magstim Rapid 2 stimulator)Device
Twice daily rTMS sessions involving 10 Hz in 75 trains of 4 seconds duration, with 26 seconds intertrain intervals (6,000 pulses per day) at 120% of the resting motor threshold.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated HF-rTMS | Experimental | Twice daily rTMS sessions involving 10 Hz in 75 trains of 4 seconds duration, with 26 seconds intertrain intervals (6,000 pulses per day) at 120% of the resting motor threshold. Receives: Device: Accelerated HF-rTMS (Magstim Rapid 2 stimulator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptomatology - Clinician Version
Response to treatment is defined as a ≥ 50% reduction in the scores of the QIDS-C. Remission is defined as a QIDS-C score ≤ 5.
Measured: Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCELO T. BERLIM, Douglas Mental Health University Institute
- Investigators
- Marcelo Berlim, MD, MSc, Principal investigator, McGill University - Dept of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125799
- Sponsor's protocol ID
- ERB12/38
- Other IDs
- IRB12/38
- Status last verified
- Oct 2014
- First submitted
- 25 Apr 2014
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial on the Effectiveness and Tolerability of Accelerated High Frequency Repetitive Transcranial Magnetic Stimulation for Treating Resistant Major Depression
- ClinicalTrials.gov ID
- NCT02125799
- Acronym / sponsor ID
- ERB12/38
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Apr 2014 (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.
High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has shown safety and efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks. Accelerated HF-TMS (aHF-rTMS), in which all treatments are delivered in less time, would have significant advantages in terms of access, patient acceptance and costs. In the present open label trial the investigators intend to assess the effectiveness and acceptability of a novel aHF-rTMS protocol (i.e., 2 daily sessions over 2 consecutive weeks; 6,000 pulses per day). For this, depressed outpatients will receive the aHF-rTMS protocol and will be assessed at baseline and at weeks 3 and 9 with several clinician- and patient- reported measures as well as with computerized neurocognitive tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerated HF-rTMS | Experimental | Device: Accelerated HF-rTMS (Magstim Rapid 2 stimulator)Twice daily rTMS sessions involving 10 Hz in 75 trains of 4 seconds duration, with 26 seconds intertrain intervals (6,000 pulses per day) at 120% of the resting motor threshold. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after ≥ 2 adequate antidepressant trial(s) in the current episode;
- Baseline score ≥ 13 on the QIDS-C
- Stable medication regimen (>= 4 weeks) prior to study enrolment
Key exclusion criteria (8 listed)
- Psychotic features in the current episode
- Lifetime history of psychotic disorders and/or bipolar I or II disorders
- Substance or alcohol abuse/dependence in the past 6 months
- Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
- Uncontrolled medical disease (e.g., cardiovascular, renal)
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 |
|---|---|---|
| Accelerated HF-rTMS (Magstim Rapid 2 stimulator)Twice daily rTMS sessions involving 10 Hz in 75 trains of 4 seconds duration, with 26 seconds intertrain intervals (6,000 pulses per day) at 120% of the resting motor threshold. | Device | Accelerated HF-rTMS |
Primary outcome
Quick Inventory of Depressive Symptomatology - Clinician Version
Time frame: Week 3
Response to treatment is defined as a ≥ 50% reduction in the scores of the QIDS-C. Remission is defined as a QIDS-C score ≤ 5.
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 6 Oct 2014.
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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.
Marcelo Berlim, MD, MSc principal investigator
McGill University - Dept of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Accelerated HF-rTMS (Magstim Rapid 2 stimulator) in people with Major Depressive Disorder, run by Douglas Mental Health University Institute 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 8 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 6 Oct 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Quick Inventory of Depressive Symptomatology - Clinician Version (time frame: Week 3). 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 6 Oct 2014.