DepressionPhase 4NCT00920322
Repetitive Transcranial Magnetic Stimulation (rTMS) in Depression
A Phase 4 study testing rTMS 5 x weekly and rTMS 3 times weekly in people with Depression, run by Northside Clinic, Australia at 1 site in Australia.
Trial summary
This study will report on the outcomes of rTMS administered 3 times per week, compared with the standard protocol of 5 times per week. Participants will be randomly assigned to frequency condition and depressive symptomatology will be measured weekly using a range of clinician and self-rated questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- rTMS 5 x weekly and rTMS 3 times weekly
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- May 2009to Aug 2011
- Phase
- Phase 4
- 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
- Aged >/= 18
- DSM-IV diagnosis of Major Depressive Episode (bipolar or MDD)
- MADRS score >/= 20
- Able to give informed consent
- Psychoactive medication dosages have been stable for a period of 4 weeks prior to entry in the study
Who cannot join
- Co-morbid alcohol or drug abuse or dependence (last 3 months), current eating disorder, mental retardation, schizophrenia, rapid cycling bipolar
- A history of mood 'switching' in response to other treatments, which cannot be contained by concurrent treatment, e.g., mood stabiliser
- Pregnancy
- Significant neurological disorder that increases seizure risk
- Metal objects in the head, pacemakers, or a history of epilepsy
- Patients who have failed to respond to a course of ECT in their current episode of depression
- A high risk of suicide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Study of rTMS in Depression
This study will report on the outcomes of rTMS administered 3 times per week, compared with the standard protocol of 5 times per week. Participants will be randomly assigned to frequency condition and depressive symptomatology will be measured weekly using a range of clinician and self-rated questionnaires. Participants will remain in the study for at least 4 weeks, with the option of continuing for a further 2 weeks as judged by the study psychiatrist. It is hypothesised that rTMS administered three times per week will be equally as effective as rTMS administered five times per week in reducing depressive symptomatology.
Read the detailed description
Numerous studies have demonstrated the efficacy of active rTMS over sham rTMS for depression; however, few have systematically studied the optimal frequency of treatment sessions to achieve this efficacy. To date, the majority of studies have administered rTMS every weekday, although this approach has not been widely contested. In addition, most studies have only assessed the effectiveness of rTMS over a two week period, which has resulted in some improvement in depressive symptomatology; however, a longer treatment course would likely result in greater improvement. In this study depressed patients will be randomly assigned to receive rTMS either 3 or 5 times per week, for a period of 4-6 weeks. A range of rating scales will be used to assess the improvement of depressive symptomatology within and between the two frequency groups, to ultimately determine whether TMS is needed 5 times per week to achieve adequate anti-depressant effects or whether 3 times per week is sufficient in achieving a similar level of efficacy for patients.
- Conditions
- Depression
- Being tested
- rTMS 5 x weekly, rTMS 3 times weekly
- Keywords
- Depression, Transcranial Magnetic Stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS 5 x weeklyDevice
Patients will receive rTMS five times weekly for 4 weeks
rTMS 3 times weeklyDevice
Patients will receive rTMS 3 times weekly for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| five times weekly | Active comparator | Patients will receive rTMS on each weekday for 4 weeks (5 x weekly) Receives: Device: rTMS 5 x weekly |
| three times weekly | Experimental | Patients will receive rTMS three times weekly for four weeks Receives: Device: rTMS 3 times weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Rating Scales
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Why it stopped: Technical issues impeded recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northside Clinic, Australia
- Sponsor type
- University, hospital or other
- Investigators
- Colleen Loo, MBBS, FRANZCP, MD, Principal investigator, University of NSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920322
- Sponsor's protocol ID
- NSG HREC 153
- Other IDs
- UNSW HREC 9074
- Status last verified
- Jul 2011
- First submitted
- 11 Jun 2009
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study of rTMS in Depression
- ClinicalTrials.gov ID
- NCT00920322
- Acronym / sponsor ID
- NSG HREC 153
- Conditions
- Depression
- Keywords
- Depression, Transcranial Magnetic Stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical issues impeded recruitment.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Northside Clinic, AustraliaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 15 Jun 2009 (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 report on the outcomes of rTMS administered 3 times per week, compared with the standard protocol of 5 times per week. Participants will be randomly assigned to frequency condition and depressive symptomatology will be measured weekly using a range of clinician and self-rated questionnaires. Participants will remain in the study for at least 4 weeks, with the option of continuing for a further 2 weeks as judged by the study psychiatrist. It is hypothesised that rTMS administered three times per week will be equally as effective as rTMS administered five times per week in reducing depressive symptomatology.
Detailed description
Numerous studies have demonstrated the efficacy of active rTMS over sham rTMS for depression; however, few have systematically studied the optimal frequency of treatment sessions to achieve this efficacy. To date, the majority of studies have administered rTMS every weekday, although this approach has not been widely contested. In addition, most studies have only assessed the effectiveness of rTMS over a two week period, which has resulted in some improvement in depressive symptomatology; however, a longer treatment course would likely result in greater improvement. In this study depressed patients will be randomly assigned to receive rTMS either 3 or 5 times per week, for a period of 4-6 weeks. A range of rating scales will be used to assess the improvement of depressive symptomatology within and between the two frequency groups, to ultimately determine whether TMS is needed 5 times per week to achieve adequate anti-depressant effects or whether 3 times per week is sufficient in achieving a similar level of efficacy for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| five times weekly | Active comparator | Device: rTMS 5 x weeklyPatients will receive rTMS on each weekday for 4 weeks (5 x weekly) |
| three times weekly | Experimental | Device: rTMS 3 times weeklyPatients will receive rTMS three times weekly for four weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged >/= 18
- DSM-IV diagnosis of Major Depressive Episode (bipolar or MDD)
- MADRS score >/= 20
- Able to give informed consent
- Psychoactive medication dosages have been stable for a period of 4 weeks prior to entry in the study
Key exclusion criteria (7 listed)
- Co-morbid alcohol or drug abuse or dependence (last 3 months), current eating disorder, mental retardation, schizophrenia, rapid cycling bipolar
- A history of mood 'switching' in response to other treatments, which cannot be contained by concurrent treatment, e.g., mood stabiliser
- Pregnancy
- Significant neurological disorder that increases seizure risk
- Metal objects in the head, pacemakers, or a history of epilepsy
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 5 x weeklyPatients will receive rTMS five times weekly for 4 weeks | Device | five times weekly |
| rTMS 3 times weeklyPatients will receive rTMS 3 times weekly for 4 weeks | Device | three times weekly |
Primary outcome
Depression Rating Scales
Time frame: weekly
Results and safety
The study was stopped early (reason given: Technical issues impeded recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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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.
Colleen Loo, MBBS, FRANZCP, MD principal investigator
University of NSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rTMS 5 x weekly and rTMS 3 times weekly in people with Depression, run by Northside Clinic, Australia at 1 site in Australia.
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: stopped early, as of the sponsor's last update on 21 Jul 2011. 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 Australia. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Technical issues impeded recruitment.). Results are not available in the source record.
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?
Depression Rating Scales (time frame: weekly). 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 21 Jul 2011.