SchizophreniaNCT02842034
Repetitive Transcranial Magnetic Stimulation for the Treatment of Negative Symptoms in Schizophrenia Patients.
A study testing Repetitive Transcranial Magnetic Stimulation in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This study is to determine whether high frequency repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia patients Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- 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
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Dec 2018
- 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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The diagnosis of schizophrenia according to DSM-IV；
- 18～55 years old；
- schizophrenic illness duration longer than one year;
- The sum of negative scores in the range Positive and negative symptom score (PANSS) must be 20 points or higher, at least one item from the area of negative symptoms (N1-N7) must be ≥ 4 points (at least moderate, clinically significant symptoms), and improvement in negative symptom-sum (measuring by PANSS) must be 10% or lower during the last two weeks before rTMS stimulation.
- Have a stable and consistent drug treatment at least two weeks prior the rTMS treatment;
- Able to adhere to the treatment schedule;
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- IQ≥80;
- Dextromanual, normal vision and hearing;
- Signed an informed consent
Who cannot join
- rTMS contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure;
- Acute risk of suicide and impulse；
- patients to be diagnosed according to DSM-IV for substance abused, development delayed;
- suffering from serious physical disease and can not accept the treatment;
- history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG;
- difficult to maintain the current drug treatment for at least 1 month;
- undergoing ECT or MECT in last 3 months;
- current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200030
Dengtang Liu, MD, +862164387250-73775, erliu110@126.com
About this study
Official title: A Randomized Double-blind Controlled Study of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia Patients.
This study is to determine whether high frequency repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia patients
Read the detailed description
The principal objective of this trial is to investigate the effect of high frequency rTMS on negative symptoms in schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- schizophrenia, rTMS
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Stimulate the dorsomedial prefrontal cortex for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Active comparator | Active treatment will be delivered at an intensity that is 120% of the resting motor threshold (RMT). Stimulation will be delivered at 10 Hz with 60 stimulation trains of 50 stimuli each (i.e., 3000 stimuli) and an intertrain interval of 10 sec. Treatment will be applied in sequential order to the dorsomedial prefrontal cortices (DMPFC). Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Sham rTMS | Sham comparator | Sham stimulation will be delivered using the same stimulation parameters and at the same site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in clinical improvement of negative symptoms (Scale for Assessment of Negative Symptoms [SANS], and Positive and Negative Syndrome Scale [PANSS] negative symptoms subscale)
Measured: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Secondary outcomes (6)
Change from baseline in Positive and Negative Syndrome Scale [PANSS] positive symptoms subscale
Measured: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in Calgary Depression Scale for Schizophrenia [CDSS]
Measured: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in clinical global impression [CGI]
Measured: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in WHO Disability Assessment Schedule 2.0 [WHODAS 2.0]
Measured: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in Simpson-Angus Scale [SAS]
Measured: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in Clinician Rated Dimensions of Psychosis Symptom [CRDPS]
Measured: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (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 Shanghai Mental Health CenterThe 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, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842034
- Sponsor's protocol ID
- rTMS-negative symptoms
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Controlled Study of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia Patients.
- ClinicalTrials.gov ID
- NCT02842034
- Acronym / sponsor ID
- rTMS-negative symptoms
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, rTMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Jul 2016 (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.
This study is to determine whether high frequency repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia patients
Detailed description
The principal objective of this trial is to investigate the effect of high frequency rTMS on negative symptoms in schizophrenia.
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 | Device: Repetitive Transcranial Magnetic StimulationActive treatment will be delivered at an intensity that is 120% of the resting motor threshold (RMT). Stimulation will be delivered at 10 Hz with 60 stimulation trains of 50 stimuli each (i.e., 3000 stimuli) and an intertrain interval of 10 sec. Treatment will be applied in sequential order to the dorsomedial prefrontal cortices (DMPFC). |
| Sham rTMS | Sham comparator | Device: Repetitive Transcranial Magnetic StimulationSham stimulation will be delivered using the same stimulation parameters and at the same site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects. |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- The diagnosis of schizophrenia according to DSM-IV；
- 18～55 years old；
- schizophrenic illness duration longer than one year;
- The sum of negative scores in the range Positive and negative symptom score (PANSS) must be 20 points or higher, at least one item from the area of negative symptoms (N1-N7) must be ≥ 4 points (at least moderate, clinically significant symptoms), and improvement in negative symptom-sum (measuring by PANSS) must be 10% or lower during the last two weeks before rTMS stimulation.
- Have a stable and consistent drug treatment at least two weeks prior the rTMS treatment;
Key exclusion criteria (8 listed)
- rTMS contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure;
- Acute risk of suicide and impulse；
- patients to be diagnosed according to DSM-IV for substance abused, development delayed;
- suffering from serious physical disease and can not accept the treatment;
- history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG;
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 StimulationStimulate the dorsomedial prefrontal cortex for 4 weeks. | Device | Active rTMS, Sham rTMS |
Primary outcome
Change from baseline in clinical improvement of negative symptoms (Scale for Assessment of Negative Symptoms [SANS], and Positive and Negative Syndrome Scale [PANSS] negative symptoms subscale)
Time frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
6 secondary outcomes
Change from baseline in Positive and Negative Syndrome Scale [PANSS] positive symptoms subscale
Time frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in Calgary Depression Scale for Schizophrenia [CDSS]
Time frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in clinical global impression [CGI]
Time frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in WHO Disability Assessment Schedule 2.0 [WHODAS 2.0]
Time frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in Simpson-Angus Scale [SAS]
Time frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in Clinician Rated Dimensions of Psychosis Symptom [CRDPS]
Time frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
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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.
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 Schizophrenia, run by Shanghai Mental Health Center at 1 site 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 9 inclusion and 8 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 26 Feb 2018. 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 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.
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 Dengtang Liu, MD (+86 21 64387250-73775, erliu110@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in clinical improvement of negative symptoms (Scale for Assessment of Negative Symptoms [SANS], and Positive and Negative Syndrome Scale [PANSS] negative symptoms subscale) (time frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)). 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 26 Feb 2018.