Adolescent DepressionPhase 1/2NCT01170520
Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents
A Phase 1/2 study testing repetitive transcranial Stimulation in people with Adolescent Depression, run by Shalvata Mental Health Center at 2 sites in Israel.
Trial summary
The investigators hypothesis that repetitive transcranial Stimulation (rTMS) is a safe and effective add-on therapy for resistent depression in adolescent patients. A group of adolescents suffering from non psychotic major depression that was resistant to at least 2 drug trials and a trail of psychotherapy will be… Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Adolescent Depression
- What is being tested?
- repetitive transcranial Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesIsrael
- Study dates
- Aug 2010to Sep 2013
- 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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 15-18 years old
- Right hand dominant
- Suffering from major depression
- CDRS > 60
- At least 3 months of current depressive episode
- Failed 2 drug trials (or 3 drug trials if trial terminated prematurely due to side effects) and at least 1 course of psychotherapy
- No contraindication for rtms (safety questionnaire)
- No change in pharmacotherapy in the last month
Who cannot join
- Schizophrenia or psychotic symptoms
- Hypertension
- Epilepsy
- History of major head trauma
- Metal implements in the head
- History of neurosurgery
Show all 13Show fewer
- History of severe head migraine
- History of hearing loss or sp cochlear transplantation
- Pregnancy
- Current drug abuse
- Unstable medical condition
- History of manic episode
- Current treatment with lithium or tricyclic or tetracyclic antidepressants
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Not yet recruiting
Shalvata Mental health Center
Hod HaSharon
Yuval Bloch, MD, 972-97478644
Yuval Bloch, MD
- Recruiting
Shalvata Mental Health Center
Hod HaSharon
Yuval Bloch, MD, 972-9-7478510, yuvalbl@clalit.org.il
About this study
Official title: The Addition of rTMS to the Therapy of Adolescents That Suffer From Treatment Resistant Depression: An Open Label Study
The investigators hypothesis that repetitive transcranial Stimulation (rTMS) is a safe and effective add-on therapy for resistent depression in adolescent patients.
A group of adolescents suffering from non psychotic major depression that was resistant to at least 2 drug trials and a trail of psychotherapy will be recruited. After an informed consent procedure for both parents and patients, patients will go through a clinical and cognitive evaluation. They will receive a protocol of 4 weeks (20 work days) of rTMS using the figure of 8 magstim coil at 100% threshold, 42 trains of 4 seconds each, intertrain interval of 30 sec to the LDPC, 1680 pulses per day. Then they will be reevaluated.
- Conditions
- Adolescent Depression
- Being tested
- repetitive transcranial Stimulation
- Keywords
- adolescent resistant depression, repetitive transcranial magnetic stimulation, treatment of resistant adolescent depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial StimulationDevice
rTMS using the figure of 8 magstim for 4 weeks or 20 work days, using 100% threshold to the LDPFC 42 trains per day 4 sec pretrain inter train interval of 30 sec.
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Experimental | Not described Receives: Device: repetitive transcranial Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Depression Rating Scale (CDRS) comparison before after therapy
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170520
- Sponsor's protocol ID
- HT 4953
- Status last verified
- Jan 2012
- First submitted
- 23 Jul 2010
- Last updated
- 5 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Addition of rTMS to the Therapy of Adolescents That Suffer From Treatment Resistant Depression: An Open Label Study
- ClinicalTrials.gov ID
- NCT01170520
- Acronym / sponsor ID
- HT 4953
- Conditions
- Adolescent Depression
- Keywords
- adolescent resistant depression, repetitive transcranial magnetic stimulation, treatment of resistant adolescent depression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2013 (estimated)
- First posted
- 27 Jul 2010 (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.
The investigators hypothesis that repetitive transcranial Stimulation (rTMS) is a safe and effective add-on therapy for resistent depression in adolescent patients.
A group of adolescents suffering from non psychotic major depression that was resistant to at least 2 drug trials and a trail of psychotherapy will be recruited. After an informed consent procedure for both parents and patients, patients will go through a clinical and cognitive evaluation. They will receive a protocol of 4 weeks (20 work days) of rTMS using the figure of 8 magstim coil at 100% threshold, 42 trains of 4 seconds each, intertrain interval of 30 sec to the LDPC, 1680 pulses per day. Then they will be reevaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS | Experimental | Device: repetitive transcranial Stimulation |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 15-18 years old
- Right hand dominant
- Suffering from major depression
- CDRS > 60
- At least 3 months of current depressive episode
Key exclusion criteria (13 listed)
- Schizophrenia or psychotic symptoms
- Hypertension
- Epilepsy
- History of major head trauma
- Metal implements in the head
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 |
|---|---|---|
| repetitive transcranial StimulationrTMS using the figure of 8 magstim for 4 weeks or 20 work days, using 100% threshold to the LDPFC 42 trains per day 4 sec pretrain inter train interval of 30 sec. | Device | rTMS |
Primary outcome
Child Depression Rating Scale (CDRS) comparison before after therapy
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
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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.
2 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 repetitive transcranial Stimulation in people with Adolescent Depression, run by Shalvata Mental Health Center at 2 sites in Israel.
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 8 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: status not confirmed, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuval Bloch, MD (972-506264628, yuvalbl@clalit.org.il; aviva100@bezeqint.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Depression Rating Scale (CDRS) comparison before after therapy (time frame: 4 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 5 Jan 2012.