Major DepressionPhase 4NCT00806143
Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression
A Phase 4 study testing repetitive transcranial stimulation (rTMS) and unilateral stimulation in people with Major Depression, run by Institute of Neuroscience, Florence, Italy at 1 site in Italy.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) has been recently FDA approved for the treatment of resistant depression. No accordance exists on which are the involved mechanisms of action and on which stimulation parameters, frequency and side are optimal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- repetitive transcranial stimulation (rTMS) and unilateral stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2008to Jan 2009
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic and Statistical Manual-IV criteria for Depressive Major Episode Hamilton Rating Scale for Depression -28 (Ham-D)score ≥ 18
- Failure to respond to a minimum of two courses of antidepressant medications for at least 6 weeks
Who cannot join
- Any comorbid axis I disorder (except simple and social phobia)
- Any other significant medical, particularly neurologic, illnesses (seizures, head trauma and brain lesions)
Trial locations and contacts
1 site in 1 country.
About this study
Repetitive transcranial magnetic stimulation (rTMS) has been recently FDA approved for the treatment of resistant depression. No accordance exists on which are the involved mechanisms of action and on which stimulation parameters, frequency and side are optimal.
Read the detailed description
To compare these different procedures we study patients with unipolar recurrent resistant major depressive disorder in a double-blind, controlled trial randomized to either sequential bilaterally on the right and left dorsolateral prefrontal cortex (DLPFC) or monolaterally on the right DLPFC. Patients will be randomized to receive sequentially low-frequency rTMS at 1 Hz to the right DLPFC and high-frequency rTMS at 10 Hz rTMS to the left DLPFC, or to receive low-frequency rTMS at 1 Hz to the right DLPFC. Significant antidepressant effect as expressed by a reduction of Hamilton Depression Scale score will be recorded in both the groups of patients.
- Conditions
- Major Depression
- Being tested
- repetitive transcranial stimulation (rTMS), unilateral stimulation
- Keywords
- Depression, TMS
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial stimulation (rTMS)Device
Repetitive TMS will be administered using a MAGSTIM rapid magnetic stimulator (Magstim Company, Ltd., Whitland, U.K.) and a 70-mm figure-eight shaped coils.
In monolateral treatment in right DLPFC, three 140-second trains will be applied at 1 Hz and at 110% of RMT. There is a 30 seconds intertrain interval (total of 420 stimuli per session). In sequential treatment, the stimulation will be applied in the first to the right and then to the left dorsolateral prefrontal cortex. In right DLPFC will be applied three 140-second trains at 1 Hz and at 110% of RMT. There will be a 30 seconds intertrain interval (total of 420 stimuli per session). In left DLPFC will be applied twenty 5-second trains were applied at 10 Hz and at 100% of RMT. There will be a 25-second intertrain interval (total of 1000 stimuli per session). Patients will be treated from Monday to Friday, for a total of 15 days.
unilateral stimulationDevice
Patients will be treated from Monday to Friday, for a total of 15 days in the same timeframe of the active group right sided low frequency stimulation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | patients will undergo sequential bilateral rTMS treatment Receives: Device: repetitive transcranial stimulation (rTMS) |
| 2 | Active comparator | patients will undergo unilateral low frequency right sided DLPFC rTMS Receives: Device: unilateral stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale (HAM-D)
Measured: at baseline and 3rd week
Secondary outcomes (1)
Clinical Global Impression Scale (CGI)
Measured: baseline and 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionJan 2009
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 Major 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Neuroscience, Florence, Italy
- Sponsor type
- University, hospital or other
- Investigators
- Stefano Pallanti, md, Principal investigator, Istituto di Neuroscienze
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806143
- Sponsor's protocol ID
- TMSDEP
- Status last verified
- Feb 2011
- First submitted
- 8 Dec 2008
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pallanti S, Bernardi S, Di Rollo A, Antonini S, Quercioli L. Unilateral low frequency versus sequential bilateral repetitive transcranial magnetic stimulation: is simpler better for treatment of resistant depression? Neuroscience. 2010 May 5;167(2):323-8. doi: 10.1016/j.neuroscience.2010.01.063. Epub 2010 Feb 9.
PubMed 20144692
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression
- ClinicalTrials.gov ID
- NCT00806143
- Acronym / sponsor ID
- TMSDEP
- Conditions
- Major Depression
- Keywords
- Depression, TMS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Institute of Neuroscience, Florence, ItalyUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Dec 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.
Repetitive transcranial magnetic stimulation (rTMS) has been recently FDA approved for the treatment of resistant depression. No accordance exists on which are the involved mechanisms of action and on which stimulation parameters, frequency and side are optimal.
Detailed description
To compare these different procedures we study patients with unipolar recurrent resistant major depressive disorder in a double-blind, controlled trial randomized to either sequential bilaterally on the right and left dorsolateral prefrontal cortex (DLPFC) or monolaterally on the right DLPFC. Patients will be randomized to receive sequentially low-frequency rTMS at 1 Hz to the right DLPFC and high-frequency rTMS at 10 Hz rTMS to the left DLPFC, or to receive low-frequency rTMS at 1 Hz to the right DLPFC. Significant antidepressant effect as expressed by a reduction of Hamilton Depression Scale score will be recorded in both the groups of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: repetitive transcranial stimulation (rTMS)patients will undergo sequential bilateral rTMS treatment |
| 2 | Active comparator | Device: unilateral stimulationpatients will undergo unilateral low frequency right sided DLPFC rTMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnostic and Statistical Manual-IV criteria for Depressive Major Episode Hamilton Rating Scale for Depression -28 (Ham-D)score ≥ 18
- Failure to respond to a minimum of two courses of antidepressant medications for at least 6 weeks
Key exclusion criteria (2 listed)
- Any comorbid axis I disorder (except simple and social phobia)
- Any other significant medical, particularly neurologic, illnesses (seizures, head trauma and brain lesions)
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 stimulation (rTMS)Repetitive TMS will be administered using a MAGSTIM rapid magnetic stimulator (Magstim Company, Ltd., Whitland, U.K.) and a 70-mm figure-eight shaped coils. In monolateral treatment in right DLPFC, three 140-second trains will be applied at 1 Hz and at 110% of RMT. There is a 30 seconds intertrain interval (total of 420 stimuli per session). In sequential treatment, the stimulation will be applied in the first to the right and then to the left dorsolateral prefrontal cortex. In right DLPFC will be applied three 140-second trains at 1 Hz and at 110% of RMT. There will be a 30 seconds intertrain interval (total of 420 stimuli per session). In left DLPFC will be applied twenty 5-second trains were applied at 10 Hz and at 100% of RMT. There will be a 25-second intertrain interval (total of 1000 stimuli per session). Patients will be treated from Monday to Friday, for a total of 15 days. | Device | 1 |
| unilateral stimulationPatients will be treated from Monday to Friday, for a total of 15 days in the same timeframe of the active group right sided low frequency stimulation | Device | 2 |
Primary outcome
Hamilton Depression Scale (HAM-D)
Time frame: at baseline and 3rd week
1 secondary outcome
Clinical Global Impression Scale (CGI)
Time frame: baseline and 3rd week
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 24 Feb 2011.
- Derived from this study: PubMed 20144692Pallanti S, Bernardi S, Di Rollo A, Antonini S, Quercioli L. Unilateral low frequency versus sequential bilateral repetitive transcranial magnetic stimulation: is simpler better for treatment of resistant depression? Neuroscience. 2010 May 5;167(2):323-8. doi: 10.1016/j.neuroscience.2010.01.063. Epub 2010 Feb 9.
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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.
Stefano Pallanti, md principal investigator
Istituto di Neuroscienze
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 repetitive transcranial stimulation (rTMS) and unilateral stimulation in people with Major Depression, run by Institute of Neuroscience, Florence, Italy at 1 site in Italy.
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 2 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 24 Feb 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 Italy. 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 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.
What does the primary outcome measure?
Hamilton Depression Scale (HAM-D) (time frame: at baseline and 3rd week). 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 NCT00806143, 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 24 Feb 2011; AzTrials last refreshed its copy on 26 Oct 2026.