DepressionPhase 1/2NCT00470028
Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents
A Phase 1/2 study testing Transcranial Magnetic Stimulation in people with Depression, run by The University of New South Wales at 3 sites in Australia.
Trial summary
This is a study to assess the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) as a treatment for depressed 13-18 year olds. In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of the brain depolarizing neurons. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depression
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 3 sitesAustralia
- Study dates
- Apr 2005to Nov 2009
- Phase
- Phase 1/2
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- DSM-IV Major Depressive Episode of no more then 3 years.
- Montgomery-Asberg Depression Rating Scale score of 20 or more.
- Aged between 13 and 18.
- May or may not be taking antidepressant medication.
Who cannot join
- Patient (or family is patient is under 18)not able to give informed consent.
- Failure to respond to ECT in current or past episodes of depression.
- Significant other Axis 1 psychiatric disorders e.g. schizophrenia.
- In imminent physical or psychological danger and needs a rapid clinical response due to inanition, psychosis or high suicide risk.
- Drug or alcohol abuse currently or in the last month.
- History of neurological illness e.g. epilepsy; neurosurgical procedure
- Mental in the cranium, a pacemaker, cochlear implant, medication pump or other electronic device.
- Women of child-bearing age whom pregnancy cannot be ruled out.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Northside Clinic
Greenwich, New South Wales, 2065
Alfred Psychiatry Research Centre, The Alfred and Monash University Department of Psychological Medicine, The Alfred Hospital
Melbourne, Victoria, 3004
Black Institute Building, School of Psychiatry, University of New South Wales
Sydney, New South Wales, 2031
About this study
Official title: A Study of Transcranial Magnetic Stimulation (TMS) Treatment in Depressed Adolescents
This is a study to assess the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) as a treatment for depressed 13-18 year olds.
In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of the brain depolarizing neurons. No anesthetic is required and the treatment in subconvulsive. Recent studies suggest that rTMS can be an effective treatment for depressive illness in adults (Loo and Mitchell, 2005) and appears to be quite safe.
Read more
Minimal data of TMS use in adolescents psychiatric disorders. Data only existed in seven patients of the four that were depressed two showed improvement in their depression (Quintana, 2005). No sham-controlled studies have been conducted.
The investigators wish to assess this in a sham-controlled study of 30 adolescents. The investigators hypothesize that rTMS will have an antidepressant effect and produce no neuropsychological impairment.
Read the detailed description
The study has two phases: the sham-controlled phase and an open phase.
Sham-controlled Phase
Participants are randomly assigned to an active or sham TMS condition.
Open Phase
Following the sham controlled period participants participants in the sham rTMS condition will be offered active rTMS. Participants will have the opportunity to receive up to 6 weeks of active rTMS.
- Conditions
- Depression
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- TMS, Treatment, Adolescents, Safety, Efficacy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
All measures at baseline and at the end of each week of treatment in the blind phase and after every 2 weeks of treatment in the open phase.
Montgomery-Asberg Depression Rating Scale (MADRS)
Clinical Global Impressions Scale (CGI)
Secondary outcomes (8)
All measures at baseline, at the end of the 4 week blind phase and at end of treatment in the open phase.
Rey Auditory Verbal Learning Test (RAVLT)
Digit span forwards and backwards and Digit symbols (WAIS)
Tower of London
Verbal Fluency
Trail A, B
Beck Depression Inventory
Centre for Epidemiological Studies - Depression - Child (CES-DC) scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startApr 2005
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Low recruitment.
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney, Monash University
- Investigators
- Colleen Loo, FRANZCP; MD, Principal investigator, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470028
- Sponsor's protocol ID
- 04263
- Status last verified
- Nov 2009
- First submitted
- 3 May 2007
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Loo C, McFarquhar T, Walter G. Transcranial magnetic stimulation in adolescent depression. Australas Psychiatry. 2006 Mar;14(1):81-5. doi: 10.1080/j.1440-1665.2006.02251.x.
PubMed 16630205
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Transcranial Magnetic Stimulation (TMS) Treatment in Depressed Adolescents
- ClinicalTrials.gov ID
- NCT00470028
- Acronym / sponsor ID
- 04263
- Conditions
- Depression
- Keywords
- TMS, Treatment, Adolescents, Safety, Efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- University of Sydney, Monash University
- Study start
- Apr 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 May 2007 (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 is a study to assess the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) as a treatment for depressed 13-18 year olds.
In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of the brain depolarizing neurons. No anesthetic is required and the treatment in subconvulsive. Recent studies suggest that rTMS can be an effective treatment for depressive illness in adults (Loo and Mitchell, 2005) and appears to be quite safe.
Minimal data of TMS use in adolescents psychiatric disorders. Data only existed in seven patients of the four that were depressed two showed improvement in their depression (Quintana, 2005). No sham-controlled studies have been conducted.
The investigators wish to assess this in a sham-controlled study of 30 adolescents. The investigators hypothesize that rTMS will have an antidepressant effect and produce no neuropsychological impairment.
Detailed description
The study has two phases: the sham-controlled phase and an open phase.
Sham-controlled Phase
Participants are randomly assigned to an active or sham TMS condition.
Open Phase
Following the sham controlled period participants participants in the sham rTMS condition will be offered active rTMS. Participants will have the opportunity to receive up to 6 weeks of active rTMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- DSM-IV Major Depressive Episode of no more then 3 years.
- Montgomery-Asberg Depression Rating Scale score of 20 or more.
- Aged between 13 and 18.
- May or may not be taking antidepressant medication.
Key exclusion criteria (8 listed)
- Patient (or family is patient is under 18)not able to give informed consent.
- Failure to respond to ECT in current or past episodes of depression.
- Significant other Axis 1 psychiatric disorders e.g. schizophrenia.
- In imminent physical or psychological danger and needs a rapid clinical response due to inanition, psychosis or high suicide risk.
- Drug or alcohol abuse currently or in the last month.
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 |
|---|---|---|
| Transcranial Magnetic Stimulation | Device | – |
Primary outcome
All measures at baseline and at the end of each week of treatment in the blind phase and after every 2 weeks of treatment in the open phase.
Montgomery-Asberg Depression Rating Scale (MADRS)
Clinical Global Impressions Scale (CGI)
8 secondary outcomes
All measures at baseline, at the end of the 4 week blind phase and at end of treatment in the open phase.
Rey Auditory Verbal Learning Test (RAVLT)
Digit span forwards and backwards and Digit symbols (WAIS)
Tower of London
Verbal Fluency
Trail A, B
Beck Depression Inventory
Centre for Epidemiological Studies - Depression - Child (CES-DC) scale
Results and safety
The study was stopped early (reason given: Low recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
- Results publication: PubMed 16630205Loo C, McFarquhar T, Walter G. Transcranial magnetic stimulation in adolescent depression. Australas Psychiatry. 2006 Mar;14(1):81-5. doi: 10.1080/j.1440-1665.2006.02251.x.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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, FRANZCP; MD principal investigator
University of New South Wales
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcranial Magnetic Stimulation in people with Depression, run by The University of New South Wales at 3 sites 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 4 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: stopped early, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Low 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?
All measures at baseline and at the end of each week of treatment in the blind phase and after every 2 weeks of treatment in the open phase.. The study lists 3 primary outcomes in all. 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 NCT00470028, 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 20 Jan 2010.