SchizophreniaPhase 3rTMSfMRINCT01370291
Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients
A Phase 3 study testing active Risperidone and active rTMS in people with Schizophrenia, run by Xijing Hospital at 2 sites in China.
Trial summary
The aim of the study is to evaluate the effects of repetitive transcranial magnetic stimulation(rTMS)in the first-episode Schizophrenic patients: the clinical and MRI findings Read more about this study
- Who is it for?
- Ages 16 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- active Risperidone and active rTMS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2011to Dec 2013
- 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 16 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 16-45 years
- Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist)
- PANSS>=60
- First episode, and the patients haven't use any antipsychotic drugs
Who cannot join
- Suicide risk
- Diagnose of substance abuse/dependance
- Severe uncontrolled organic disease that may interfere in the patient´s participation in the study
- Contraindication to TMS:
- Implanted pacemaker
- Medication pump
Show all 13Show fewer
- Vagal stimulator
- Deep brain stimulator
- Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding
- Signs of increased intracranial pressure
- Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
- Estimated IQ less than 80
- Have a sibling or parent with epilepsy
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Yun chun Chen
Xi'an, Shaanxi, 710032
Yun chun Chen, Ph.D, +086-13720582601, Yunchunchen@163.com
Shufang Feng, Ph.D, +086-13227807801, fangshuan1984@yahoo.com.cn
- Recruiting
Yun chun Chen
Xi'an, Shaanxi, 710032
Yun chun Chen, Ph.D, +086-13720582601, Yunchunchen@163.com
Shufang Feng, Ph.D, +086-13227807801, fangshuan1984@yahoo.com.cn
About this study
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) for First-episode Schizophrenia Patients:A Double-blinded , Randomized and Functional Magnetic Resonance Imaging (fMRI)Study
The aim of the study is to evaluate the effects of repetitive transcranial magnetic stimulation(rTMS)in the first-episode Schizophrenic patients: the clinical and MRI findings
- Conditions
- Schizophrenia
- Being tested
- active Risperidone and active rTMS, active rTMS and sham Risperidone, sham rTMS and active Risperidone
- Keywords
- rTMS, Risperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active Risperidone and active rTMSOther
Also called Risperidone:Xian-Janssen pharmaceutical ltd, rTMS:MagVenture
active Risperidone:------- active rTMS:auditory hallucinations:low-frequency(1Hz)applied over the left temporoparietal cortex(LTPC) negative symptoms:high-frequency（10Hz）applied over the left temporoparietal cortex(LTPC)
active rTMS and sham RisperidoneOther
Also called Risperidone:Xian-Janssen pharmaceutical ltd, rTMS: MagVenture
active Risperidone:------- ; active rTMS:auditory hallucinations:low-frequency(1Hz)applied over the left temporoparietal cortex(LTPC); negative symptoms:high-frequency（10Hz）applied over the left temporoparietal; cortex(LTPC)
sham rTMS and active RisperidoneOther
Also called Risperidone:Xian-Janssen pharmaceutical ltd, rTMS: MagVenture
active Risperidone:------- ; active rTMS:auditory hallucinations:low-frequency(1Hz)applied over the left temporoparietal cortex(LTPC); negative symptoms:high-frequency（10Hz）applied over the left temporoparietal; cortex(LTPC)
| Study group | Role | What they receive |
|---|---|---|
| active Risperidone and active rTMS | Active comparator | active Risperidone and active rTMS for the first-episode schizophrenia patients Receives: Other: active Risperidone and active rTMS |
| active rTMS and sham Risperidone | Experimental | active rTMS and sham Risperidone for the first-episode schizophrenia Receives: Other: active rTMS and sham Risperidone |
| sham rTMS and active Risperidone | Sham comparator | sham rTMS and active Risperidone for the first-episode schizophrenia patients Receives: Other: sham rTMS and active Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS
Measured: 1-6 weeks
Secondary outcomes (4)
Total AHRS score
Measured: 1-6 weeks
HAMD Score
Measured: 1-6 weeks
CGI
Measured: 1-6 weeks
fMRI
Measured: 0,6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
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 Xijing HospitalThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fengshufang, Xijing Hospital
- Investigators
- Qingrong Tan, Ph.D, Study director, Department of Psychiatry, Xi Jing hospital, Xi'an, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370291
- Sponsor's protocol ID
- 20110526-08
- Acronym
- rTMSfMRI
- Status last verified
- Feb 2012
- First submitted
- 8 Jun 2011
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) for First-episode Schizophrenia Patients:A Double-blinded , Randomized and Functional Magnetic Resonance Imaging (fMRI)Study
- ClinicalTrials.gov ID
- NCT01370291
- Acronym / sponsor ID
- rTMSfMRI / 20110526-08
- Conditions
- Schizophrenia
- Keywords
- rTMS, Risperidone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 9 Jun 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.
The aim of the study is to evaluate the effects of repetitive transcranial magnetic stimulation(rTMS)in the first-episode Schizophrenic patients: the clinical and MRI findings
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active Risperidone and active rTMS | Active comparator | Other: active Risperidone and active rTMSactive Risperidone and active rTMS for the first-episode schizophrenia patients |
| active rTMS and sham Risperidone | Experimental | Other: active rTMS and sham Risperidoneactive rTMS and sham Risperidone for the first-episode schizophrenia |
| sham rTMS and active Risperidone | Sham comparator | Other: sham rTMS and active Risperidonesham rTMS and active Risperidone for the first-episode schizophrenia patients |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age between 16-45 years
- Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist)
- PANSS>=60
- First episode, and the patients haven't use any antipsychotic drugs
Key exclusion criteria (13 listed)
- Suicide risk
- Diagnose of substance abuse/dependance
- Severe uncontrolled organic disease that may interfere in the patient´s participation in the study
- Contraindication to TMS:
- Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
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 Risperidone and active rTMSAlso: Risperidone:Xian-Janssen pharmaceutical ltd, rTMS:MagVentureactive Risperidone:------- active rTMS:auditory hallucinations:low-frequency(1Hz)applied over the left temporoparietal cortex(LTPC) negative symptoms:high-frequency（10Hz）applied over the left temporoparietal cortex(LTPC) | Other | active Risperidone and active rTMS |
| active rTMS and sham RisperidoneAlso: Risperidone:Xian-Janssen pharmaceutical ltd, rTMS: MagVentureactive Risperidone:------- ; active rTMS:auditory hallucinations:low-frequency(1Hz)applied over the left temporoparietal cortex(LTPC); negative symptoms:high-frequency（10Hz）applied over the left temporoparietal; cortex(LTPC) | Other | active rTMS and sham Risperidone |
| sham rTMS and active RisperidoneAlso: Risperidone:Xian-Janssen pharmaceutical ltd, rTMS: MagVentureactive Risperidone:------- ; active rTMS:auditory hallucinations:low-frequency(1Hz)applied over the left temporoparietal cortex(LTPC); negative symptoms:high-frequency（10Hz）applied over the left temporoparietal; cortex(LTPC) | Other | sham rTMS and active Risperidone |
Primary outcome
PANSS
Time frame: 1-6 weeks
4 secondary outcomes
Total AHRS score
Time frame: 1-6 weeks
HAMD Score
Time frame: 1-6 weeks
CGI
Time frame: 1-6 weeks
fMRI
Time frame: 0,6 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 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.
Qingrong Tan, Ph.D study director
Department of Psychiatry, Xi Jing hospital, Xi'an, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing active Risperidone and active rTMS in people with Schizophrenia, run by Xijing Hospital at 2 sites in China.
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 4 inclusion and 13 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 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunchun Chen, Ph.D (+086-13720582601, Yunchunchen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS (time frame: 1-6 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 15 Feb 2012.