Bipolar DepressionNCT00657735
Double Blind Randomized Controlled, H1 Coil In Subjects With Bipolar Depression
A study testing H-Coil deep TMS in people with Bipolar Depression, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression , currently treated with mood stabilizer and previously unsuccessfully treated with antidepressant medications Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- H-Coil deep TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Jan 2013
- Phase
- Interventional
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed by two senior psychiatrists as suffering from bipolar depression (BP1, BP2) episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID), with additional requirement of duration for the current episode ≥ 4 weeks and CGI ≥ 4.
- Rating on HAM-D (17 items) >20 and item 1 ≥2 at the screening visit.
- Age: 18-65 years.
- Gave informed consent for participation in the study.
- Negative answers on safety screening questionnaire for transcranial magnetic stimulation
- Taking mood stabilizing medication (e.g., lithium) on an acceptable range of dosage according to recent blood examination or antipsychotic medication as mood stabilizers prescribed by their treating physician
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- According to the treating physician the patient is compliant in taking the mood-stabilizing medication.
- Medication resistance to at least two different antidepressant treatments, defined as resistance to a minimum of 2 antidepressant drug trials of adequate dose and duration in the current episode or previous episodes defined as a minimum level of 3 on the ATHF per antidepressant drug-trial.
- Patients who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to 3 or more anti-depressant medications in the current or a previous episodes.
- If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents.
- Able to tolerate psychotropic medication washout and no psychotropics during the H-coil deep brain rTMS other than benzodiazepine at equivalent dose of up to 3 mg lorazepam every day.
- Right hand dominance.
- Exclusion Criteria:• Diagnosis as suffering from other diagnosis on axis 1 (like: schizophrenia, geriatric depression).
- Diagnosis as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder.
- Substantial suicidal risk as judged by the treating psychiatrist.
- Attempted suicide in the past year.
- Patients with a bipolar cycle of less than 30 days.
- History of epilepsy or seizure in first degree relatives.
- History of head injury.
- History of any metal in the head (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
- History of frequent or severe headaches.
- History of migraine.
- History of hearing loss.
- Known history of cochlear implants
- History of substance abuse within the past 6 months (except nicotine and caffeine) or alcoholism
- Pregnancy or not using a reliable method of birth control.
- Unstable Systemic and metabolic disorders.
- Unstable neurological or medical disease
- Inadequate communication with the patient.
- Under custodial care.
- Participation in current clinical study or clinical study within 30 days prior to this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Yechiel Levkovitz, MD contact
Oded Meiron, PhD student contact
About this study
Official title: A Prospective Double Blind Randomized Controlled Trial To Explore The Tolerability, Safety And Efficacy Of The H1-Coil Deep Transcranial Magnetic Stimulation (TMS) In Subjects With Bipolar Depression
The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression , currently treated with mood stabilizer and previously unsuccessfully treated with antidepressant medications
- Conditions
- Bipolar Depression
- Being tested
- H-Coil deep TMS, sham
- Keywords
- bipolar, depression, prefrontal, cortex, antidepressant, response
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-Coil deep TMSDevice
Also called H1 coil dTMS
20 daily deep rTMS treatments
shamDevice
inactive treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Deep TMS treatment Receives: Device: H-Coil deep TMS |
| 2 | Sham comparator | inactive stimulation Receives: Device: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the Hamilton depression rating scale score
Measured: 7 weeks
Secondary outcomes (1)
Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brainsway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657735
- Sponsor's protocol ID
- BR-BIP-02
- Status last verified
- Jan 2012
- First submitted
- 8 Apr 2008
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
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
- A Prospective Double Blind Randomized Controlled Trial To Explore The Tolerability, Safety And Efficacy Of The H1-Coil Deep Transcranial Magnetic Stimulation (TMS) In Subjects With Bipolar Depression
- ClinicalTrials.gov ID
- NCT00657735
- Acronym / sponsor ID
- BR-BIP-02
- Conditions
- Bipolar Depression
- Keywords
- bipolar, depression, prefrontal, cortex, antidepressant, response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Collaborators
- Brainsway
- Study start
- Jan 2009
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 14 Apr 2008 (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 purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression , currently treated with mood stabilizer and previously unsuccessfully treated with antidepressant medications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: H-Coil deep TMSDeep TMS treatment |
| 2 | Sham comparator | Device: shaminactive stimulation |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Diagnosed by two senior psychiatrists as suffering from bipolar depression (BP1, BP2) episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID), with additional requirement of duration for the current episode ≥ 4 weeks and CGI ≥ 4.
- Rating on HAM-D (17 items) >20 and item 1 ≥2 at the screening visit.
- Age: 18-65 years.
- Gave informed consent for participation in the study.
- Negative answers on safety screening questionnaire for transcranial magnetic stimulation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| H-Coil deep TMSAlso: H1 coil dTMS20 daily deep rTMS treatments | Device | 1 |
| shaminactive treatment | Device | 2 |
Primary outcome
change in the Hamilton depression rating scale score
Time frame: 7 weeks
1 secondary outcome
Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10.
Time frame: 7 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.
Yechiel Levkovitz, MD contact
Oded Meiron, PhD student contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H-Coil deep TMS 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 32 inclusion and 0 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Yechiel Levkovitz, MD (ylevk@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the Hamilton depression rating scale score (time frame: 7 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.