Mental DisordersPhase 2NCT01872143
Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders
A Phase 2 study testing transcranial Direct Current Stimulation in people with Mental Disorders, run by Federico II University at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in the treatment of psychiatric disorders in which available treatments are either ineffective or not tolerated Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to May 2014
- Phase
- Phase 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a psychiatric disorder in which available treatment are either ineffective or not tolerated
Who cannot join
- implantable active devices
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOU "Federico II" of Naples
Naples, 80131
d'urso, giordanodurso@me.com
giordano d'urso, MD, PhD
About this study
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in the treatment of psychiatric disorders in which available treatments are either ineffective or not tolerated
Read the detailed description
Depending on the specific psychiatric disorder, inhibitory or stimulating neuromodulation will be applied over the cortical region of interest, found according to the relevant scientific publication on neurophysiology of psychiatric disorders
- Conditions
- Mental Disorders
- Being tested
- transcranial Direct Current Stimulation
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current StimulationDevice
daily or twice-a-day administration of transcranial Direct Current Stimulation from a minimum of 10 session to a maximum of 20
| Study group | Role | What they receive |
|---|---|---|
| transcranial Direct Current Stimulation | Experimental | daily or twice-a-day administration of transcranial Direct Current Stimulation Receives: Device: transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Psychiatric rating scales scores at immediate post-treatment and at one-month and at three-month follow-up visits
Measured: Time points: T0=baseline; T1=immediate post-treatment; T2=one-month follow-up visit; T3=3-months follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, giordano d'urso, Federico II University
- Investigators
- giordano d'urso, MD, PhD, Principal investigator, AOU "Federico II" of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872143
- Sponsor's protocol ID
- 61/10 (Ethical Committee)
- Status last verified
- Jun 2013
- First submitted
- 16 May 2013
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT01872143
- Acronym / sponsor ID
- 61/10 (Ethical Committee)
- Conditions
- Mental Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 7 Jun 2013 (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 this study is to determine whether transcranial direct current stimulation (tDCS) is effective in the treatment of psychiatric disorders in which available treatments are either ineffective or not tolerated
Detailed description
Depending on the specific psychiatric disorder, inhibitory or stimulating neuromodulation will be applied over the cortical region of interest, found according to the relevant scientific publication on neurophysiology of psychiatric disorders
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transcranial Direct Current Stimulation | Experimental | Device: transcranial Direct Current Stimulationdaily or twice-a-day administration of transcranial Direct Current Stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a psychiatric disorder in which available treatment are either ineffective or not tolerated
Key exclusion criteria (1 listed)
- implantable active devices
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 Direct Current Stimulationdaily or twice-a-day administration of transcranial Direct Current Stimulation from a minimum of 10 session to a maximum of 20 | Device | transcranial Direct Current Stimulation |
Primary outcome
Change from Baseline Psychiatric rating scales scores at immediate post-treatment and at one-month and at three-month follow-up visits
Time frame: Time points: T0=baseline; T1=immediate post-treatment; T2=one-month follow-up visit; T3=3-months follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
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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.
giordano d'urso, MD, PhD principal investigator
AOU "Federico II" of Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing transcranial Direct Current Stimulation in people with Mental Disorders, run by Federico II University 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 1 inclusion and 1 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 7 Jun 2013. 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 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 giordano d'urso, MD, PhD (+390817462652, giordanodurso@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Psychiatric rating scales scores at immediate post-treatment and at one-month and at three-month follow-up visits (time frame: Time points: T0=baseline; T1=immediate post-treatment; T2=one-month follow-up visit; T3=3-months follow-up visit). 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 7 Jun 2013.