Bipolar DepressionPhase 1NCT00444938
Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device in the Treatment of Bipolar Depression
A Phase 1 study testing H1 -coil TMS device in people with Bipolar Depression, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
This study is evaluating the potential antidepressive effect of a 4 week treatment protocol using the H-coil deep TMS device in bipolar depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- H1 -coil TMS device
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jun 2006to Mar 2008
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of bipolar depression
Who cannot join
- No other axis I disorder
- Risk factors for convulsions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the H-Coil (TMS) Device - Safety and Feasibility in Bipolar Depression
This study is evaluating the potential antidepressive effect of a 4 week treatment protocol using the H-coil deep TMS device in bipolar depression.
- Conditions
- Bipolar Depression
- Being tested
- H1 -coil TMS device
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H1 -coil TMS deviceDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startJun 2006
- Study completionMar 2008
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 Bipolar 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Investigators
- Eiran V Harel, MD, Principal investigator, Shalvata MHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444938
- Sponsor's protocol ID
- SH-50506
- Status last verified
- Mar 2007
- First submitted
- 7 Mar 2007
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harel EV, Zangen A, Roth Y, Reti I, Braw Y, Levkovitz Y. H-coil repetitive transcranial magnetic stimulation for the treatment of bipolar depression: an add-on, safety and feasibility study. World J Biol Psychiatry. 2011 Mar;12(2):119-26. doi: 10.3109/15622975.2010.510893. Epub 2010 Sep 21.
PubMed 20854181
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the H-Coil (TMS) Device - Safety and Feasibility in Bipolar Depression
- ClinicalTrials.gov ID
- NCT00444938
- Acronym / sponsor ID
- SH-50506
- Conditions
- Bipolar Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- Mar 2008 (actual)
- First posted
- 8 Mar 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 study is evaluating the potential antidepressive effect of a 4 week treatment protocol using the H-coil deep TMS device in bipolar depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of bipolar depression
Key exclusion criteria (2 listed)
- No other axis I disorder
- Risk factors for convulsions
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 |
|---|---|---|
| H1 -coil TMS device | Device | – |
Primary outcome
Not reported in the source record.
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 Feb 2009.
- Derived from this study: PubMed 20854181Harel EV, Zangen A, Roth Y, Reti I, Braw Y, Levkovitz Y. H-coil repetitive transcranial magnetic stimulation for the treatment of bipolar depression: an add-on, safety and feasibility study. World J Biol Psychiatry. 2011 Mar;12(2):119-26. doi: 10.3109/15622975.2010.510893. Epub 2010 Sep 21.
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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.
Eiran V Harel, MD principal investigator
Shalvata MHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing H1 -coil TMS device in people with Bipolar Depression, run by Shalvata Mental Health Center at 1 site 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 1 inclusion and 2 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 Feb 2009. 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 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 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00444938, 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 Feb 2009.