SchizophreniaPhase 3NCT01015001
A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine
A Phase 3 study testing (1Hz) rTMS applied over the left temporoparietal cortex in people with Schizophrenia and Auditory Hallucinations, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The primary outcome of this study is to evaluate the effects of low frequency subthreshold repetitive Transcranial Magnetic Stimulation applied to the left temporoparietal cortex of patients with refractory schizophrenia on the severity of auditory hallucinations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Auditory Hallucinations
- What is being tested?
- (1Hz) rTMS applied over the left temporoparietal cortex
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- May 2008to Dec 2009
- Phase
- Phase 3
- 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
- Patients with DSM IV TR diagnose of schizophrenia with treatment-resistant auditory hallucinations.
- Use of at least 400mg/day of clozapine
- Men and women from 18 to 65 years old
- Fertile women must be using adequate contraceptive method
- BPRS score of at least 27
Who cannot join
- Suicide risk
- Patients with epilepsy, brain surgery and/or head trauma in the past, use of cardiac pace maker or metalic clip in the head
- Diagnose of substance abuse/dependance
- Severe uncontrolled organic disease that may interfere in the patient´s participation in the study
- Any other reason that, in the investigator´s opinion, might interfere with the patient´s participation in the study, such as non compliance.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
The primary outcome of this study is to evaluate the effects of low frequency subthreshold repetitive Transcranial Magnetic Stimulation applied to the left temporoparietal cortex of patients with refractory schizophrenia on the severity of auditory hallucinations.
The secondary outcome is to evaluate the effects of the same rTMS protocol on quality of life, functionality and general psychopathology.
Read the detailed description
Seventeen patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. First group received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).
Second group received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and refering auditory hallucinations occuring at least 5 times a day.
- Conditions
- Schizophrenia, Auditory Hallucinations
- Being tested
- Active rTMS x sham (placebo) rTMS, sham rTMS, (1Hz) rTMS applied over the left temporoparietal cortex
- Keywords
- refractory schizophrenia, rTMS, auditory hallucinations
- Medical subject headings
- Schizophrenia, Hallucinations, Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMS x sham (placebo) rTMSProcedure or surgery
Also called EMTr
Seventeen right-handed patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. One arm received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).
The other arm received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and referred auditory hallucinations.
sham rTMSProcedure or surgery
Also called Sham
same coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region
(1Hz) rTMS applied over the left temporoparietal cortexProcedure or surgery
20 sessions lasting 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Active comparator | 1Hz rTMS sessions applied to the left temporoparietal cortex of the subjects Receives: Procedure: Active rTMS x sham (placebo) rTMS; Procedure: (1Hz) rTMS applied over the left temporoparietal cortex |
| Sham rtms | Placebo comparator | Same number of pulses but applied with and angled coil (90 degrees) and placed over the fronto´temporal region Receives: Procedure: Active rTMS x sham (placebo) rTMS; Procedure: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effects of low frequency repetitive Transcranial Magnetic Stimulation applied over the left temporoparietal cortex of refractory schizophrenic patients on the severity of auditory hallucinations.
Measured: 2 years
Secondary outcomes (1)
The secondary outcomes are to evaluate the effects of the same rTMS protocol on their quality of life, functionality and general psychopathology.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Danilo Jesus, Psychiatrist, Principal investigator, Hospital de Clinicas de Porto AlegrePaulo B Abreu, phd, Study director, HCPorto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015001
- Sponsor's protocol ID
- 06382
- Status last verified
- Aug 2010
- First submitted
- 10 Nov 2009
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine
- ClinicalTrials.gov ID
- NCT01015001
- Acronym / sponsor ID
- 06382
- Conditions
- Schizophrenia, Auditory Hallucinations
- Keywords
- refractory schizophrenia, rTMS, auditory hallucinations
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Nov 2009 (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 primary outcome of this study is to evaluate the effects of low frequency subthreshold repetitive Transcranial Magnetic Stimulation applied to the left temporoparietal cortex of patients with refractory schizophrenia on the severity of auditory hallucinations.
The secondary outcome is to evaluate the effects of the same rTMS protocol on quality of life, functionality and general psychopathology.
Detailed description
Seventeen patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. First group received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).
Second group received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and refering auditory hallucinations occuring at least 5 times a day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Active comparator | Procedure: Active rTMS x sham (placebo) rTMS, Procedure: (1Hz) rTMS applied over the left temporoparietal cortex1Hz rTMS sessions applied to the left temporoparietal cortex of the subjects |
| Sham rtms | Placebo comparator | Procedure: Active rTMS x sham (placebo) rTMS, Procedure: sham rTMSSame number of pulses but applied with and angled coil (90 degrees) and placed over the fronto´temporal region |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with DSM IV TR diagnose of schizophrenia with treatment-resistant auditory hallucinations.
- Use of at least 400mg/day of clozapine
- Men and women from 18 to 65 years old
- Fertile women must be using adequate contraceptive method
- BPRS score of at least 27
Key exclusion criteria (5 listed)
- Suicide risk
- Patients with epilepsy, brain surgery and/or head trauma in the past, use of cardiac pace maker or metalic clip in the head
- Diagnose of substance abuse/dependance
- Severe uncontrolled organic disease that may interfere in the patient´s participation in the study
- Any other reason that, in the investigator´s opinion, might interfere with the patient´s participation in the study, such as non compliance.
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 |
|---|---|---|
| Active rTMS x sham (placebo) rTMSAlso: EMTrSeventeen right-handed patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. One arm received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC). The other arm received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and referred auditory hallucinations. | Procedure or surgery | Active rTMS, Sham rtms |
| sham rTMSAlso: Shamsame coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region | Procedure or surgery | Sham rtms |
| (1Hz) rTMS applied over the left temporoparietal cortex20 sessions lasting 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC). | Procedure or surgery | Active rTMS |
Primary outcome
Evaluate the effects of low frequency repetitive Transcranial Magnetic Stimulation applied over the left temporoparietal cortex of refractory schizophrenic patients on the severity of auditory hallucinations.
Time frame: 2 years
1 secondary outcome
The secondary outcomes are to evaluate the effects of the same rTMS protocol on their quality of life, functionality and general psychopathology.
Time frame: 2 years
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 12 Aug 2010.
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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.
Danilo Jesus, Psychiatrist principal investigator
Hospital de Clinicas de Porto Alegre
Paulo B Abreu, phd study director
HCPorto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing (1Hz) rTMS applied over the left temporoparietal cortex in people with Schizophrenia and Auditory Hallucinations, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 5 inclusion and 5 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 12 Aug 2010. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Evaluate the effects of low frequency repetitive Transcranial Magnetic Stimulation applied over the left temporoparietal cortex of refractory schizophrenic patients on the severity of auditory hallucinations. (time frame: 2 years). 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 12 Aug 2010.