Refractory SchizophreniaNCT01386918
Repetitive Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia
A study testing repetitive Transcranial Magnetic Stimulation in people with Refractory Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Studies using repetitive transcranial magnetic stimulation (rTMS) as a treatment for refractory auditory hallucinations (AH) in schizophrenia have shown promise. The majority of studies have examined the effect of low frequency left-sided stimulation (LFL) (i.e., 1 Hz) to the temporal parietal cortex (TPC). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Refractory Schizophrenia
- What is being tested?
- repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2004to Jan 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- voluntary and capable to consent based on the subject's ability to provide a spontaneous narrative description of the key elements of the study
- have a diagnosis of Schizophrenia or Schizoaffective Disorder as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV)
- between the ages of 18 and 65
- meet criteria for AH of at least moderate severity based on the Positive and Negative Symptom Scale (PANSS)
- willing to keep the dose of antipsychotic stable for the duration of the study
- meet criteria for medication resistance, defined as daily AH despite 2 adequate 6-week trials of at least 2 antipsychotic medications and including 1 atypical antipsychotic medication. An adequate trial is defined as a daily dose of 1000 chlorpromazine equivalents for typical antipsychotics medications and the following dosages for atypical antipsychotic medications: risperidone 6 mg, olanzapine 15 mg, quetiapine 500 mg, clozapine 300 mg.
Who cannot join
- DSM-IV history of alcohol and/or substance abuse in past month, or alcohol and/or substance dependence in the last 6 months
- presence of concomitant major, unstable medical or neurologic illness, or a history of seizures
- are pregnant
- have received rTMS for any reason in the past
- have had a dose change of usual psychotropic medications in the 4 weeks preceding study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-Blind Sham-Controlled Trial of Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia
Studies using repetitive transcranial magnetic stimulation (rTMS) as a treatment for refractory auditory hallucinations (AH) in schizophrenia have shown promise. The majority of studies have examined the effect of low frequency left-sided stimulation (LFL) (i.e., 1 Hz) to the temporal parietal cortex (TPC). Priming stimulation (6 Hz) prior to LFL stimulation (hereby simply referred to as priming) has been shown to enhance the neurophysiological effects of LFL rTMS alone and, as such, may lead to greater attenuation of AH. Therefore, this study evaluated the efficacy of priming rTMS and LFL rTMS, compared to sham, applied to the TPC in patients with schizophrenia experiencing refractory auditory hallucinations (AH).
- Conditions
- Refractory Schizophrenia
- Being tested
- repetitive Transcranial Magnetic Stimulation
- Keywords
- Hallucinations, Schizophrenia
- Medical subject headings
- Schizophrenia, Treatment-Resistant, Hallucinations, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic StimulationDevice
Also called Magstim Rapid (Magstim Company Ltd., Wales, UK)
The treatment involves the administration of a magnetic field applied to a specific area of the brain.
| Study group | Role | What they receive |
|---|---|---|
| Low frequency left (LFL) sided rTMS | Experimental | LFL rTMS was administered at an intensity of 115% resting motor threshold at 1HZ for 20 minutes. The treatment targeted the left temporoparietal cortex (TPC). Receives: Device: repetitive Transcranial Magnetic Stimulation |
| Priming stimulation | Experimental | Priming stimulation was administered as follows: 10 minutes of 6 Hz at 90% resting motor threshold (RMT) administered to the left temporoparietal cortex followed by 10 minutes of 1 Hz stimulation at 115% RMT. Receives: Device: repetitive Transcranial Magnetic Stimulation |
| Sham Control | Sham comparator | Sham stimulation was applied with identical parameters to those for the LFL condition but with the coil angled at 90 degrees off the scalp in a single wing tilt position. Receives: Device: repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychotic Symptoms Rating Scale (PSYRATS)
The primary outcome for this study was response (dichotomous outcome), defined as a 30 percent reduction in the composite score derived from the frequency, duration, loudness and content items of the hallucinations subscale of the Psychotic Symptoms Rating Scale (PSYRATS)
Measured: 4 weeks
Secondary outcomes (4)
Positive and Negative Symptom Scale - Global
response on the global PANSS (30% reduction), PANSS global scale change
Measured: 4 weeks
Positive and Negative Symptom Scale - Positive subscale
response on the positive scale of the PANSS (30% reduction), PANSS positive scale change
Measured: 4 weeks
Hallucination Change Scale
response on the HCS (score < 5)
Measured: 4 weeks
Auditory Hallucination Rating Scale (AHRS)
response on the AHRS and change over time in the AHRS.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startFeb 2004
- 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 Refractory SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Mental Health Foundation, Canadian Institutes of Health Research (CIHR), National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Principal investigator, Z. J. Daskalakis, Centre for Addiction and Mental Health
- Investigators
- Z J Daskalakis, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386918
- Sponsor's protocol ID
- 127/2003
- Status last verified
- Jan 2012
- First submitted
- 29 Jun 2011
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Blumberger DM, Christensen BK, Zipursky RB, Moller B, Chen R, Fitzgerald PB, Daskalakis ZJ. MRI-targeted repetitive transcranial magnetic stimulation of Heschl's gyrus for refractory auditory hallucinations. Brain Stimul. 2012 Oct;5(4):577-85. doi: 10.1016/j.brs.2011.12.002. Epub 2012 Feb 22.
PubMed 22410480
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Sham-Controlled Trial of Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia
- ClinicalTrials.gov ID
- NCT01386918
- Acronym / sponsor ID
- 127/2003
- Conditions
- Refractory Schizophrenia
- Keywords
- Hallucinations, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Ontario Mental Health Foundation, Canadian Institutes of Health Research (CIHR), National Alliance for Research on Schizophrenia and Depression
- Study start
- Feb 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Jul 2011 (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.
Studies using repetitive transcranial magnetic stimulation (rTMS) as a treatment for refractory auditory hallucinations (AH) in schizophrenia have shown promise. The majority of studies have examined the effect of low frequency left-sided stimulation (LFL) (i.e., 1 Hz) to the temporal parietal cortex (TPC). Priming stimulation (6 Hz) prior to LFL stimulation (hereby simply referred to as priming) has been shown to enhance the neurophysiological effects of LFL rTMS alone and, as such, may lead to greater attenuation of AH. Therefore, this study evaluated the efficacy of priming rTMS and LFL rTMS, compared to sham, applied to the TPC in patients with schizophrenia experiencing refractory auditory hallucinations (AH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low frequency left (LFL) sided rTMS | Experimental | Device: repetitive Transcranial Magnetic StimulationLFL rTMS was administered at an intensity of 115% resting motor threshold at 1HZ for 20 minutes. The treatment targeted the left temporoparietal cortex (TPC). |
| Priming stimulation | Experimental | Device: repetitive Transcranial Magnetic StimulationPriming stimulation was administered as follows: 10 minutes of 6 Hz at 90% resting motor threshold (RMT) administered to the left temporoparietal cortex followed by 10 minutes of 1 Hz stimulation at 115% RMT. |
| Sham Control | Sham comparator | Device: repetitive Transcranial Magnetic StimulationSham stimulation was applied with identical parameters to those for the LFL condition but with the coil angled at 90 degrees off the scalp in a single wing tilt position. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- voluntary and capable to consent based on the subject's ability to provide a spontaneous narrative description of the key elements of the study
- have a diagnosis of Schizophrenia or Schizoaffective Disorder as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV)
- between the ages of 18 and 65
- meet criteria for AH of at least moderate severity based on the Positive and Negative Symptom Scale (PANSS)
- willing to keep the dose of antipsychotic stable for the duration of the study
Key exclusion criteria (5 listed)
- DSM-IV history of alcohol and/or substance abuse in past month, or alcohol and/or substance dependence in the last 6 months
- presence of concomitant major, unstable medical or neurologic illness, or a history of seizures
- are pregnant
- have received rTMS for any reason in the past
- have had a dose change of usual psychotropic medications in the 4 weeks preceding study entry.
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 Magnetic StimulationAlso: Magstim Rapid (Magstim Company Ltd., Wales, UK)The treatment involves the administration of a magnetic field applied to a specific area of the brain. | Device | Low frequency left (LFL) sided rTMS, Priming stimulation, Sham Control |
Primary outcome
Psychotic Symptoms Rating Scale (PSYRATS)
Time frame: 4 weeks
The primary outcome for this study was response (dichotomous outcome), defined as a 30 percent reduction in the composite score derived from the frequency, duration, loudness and content items of the hallucinations subscale of the Psychotic Symptoms Rating Scale (PSYRATS)
4 secondary outcomes
Positive and Negative Symptom Scale - Global
Time frame: 4 weeks
Positive and Negative Symptom Scale - Positive subscale
Time frame: 4 weeks
Hallucination Change Scale
Time frame: 4 weeks
Auditory Hallucination Rating Scale (AHRS)
Time frame: 4 weeks
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 6 Jan 2012.
- Derived from this study: PubMed 22410480Blumberger DM, Christensen BK, Zipursky RB, Moller B, Chen R, Fitzgerald PB, Daskalakis ZJ. MRI-targeted repetitive transcranial magnetic stimulation of Heschl's gyrus for refractory auditory hallucinations. Brain Stimul. 2012 Oct;5(4):577-85. doi: 10.1016/j.brs.2011.12.002. Epub 2012 Feb 22.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating CentreLink provided by the sponsor.
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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.
Z J Daskalakis, MD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation in people with Refractory Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 6 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 6 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 Canada. 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?
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?
Psychotic Symptoms Rating Scale (PSYRATS) (time frame: 4 weeks). 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 NCT01386918, 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 6 Jan 2012.