Clinical trial NCT02842034: Repetitive Transcranial Magnetic Stimulation for the Treatment of Negative Symptoms in Schizophrenia Patients.
Official title: A Randomized Double-blind Controlled Study of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
rTMS
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: The principal objective of this trial is to investigate the effect of high frequency rTMS on negative symptoms in schizophrenia.

Eligibility criteria: Inclusion Criteria:

* 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;
* IQ≥80;
* Dextromanual, normal vision and hearing;
* Signed an informed consent

Exclusion Criteria:

* 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.

Primary outcomes:
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)
timeFrame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Secondary outcomes:
measure: Change from baseline in Positive and Negative Syndrome Scale [PANSS] positive symptoms subscale
timeFrame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
measure: Change from baseline in Calgary Depression Scale for Schizophrenia [CDSS]
timeFrame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
measure: Change from baseline in clinical global impression [CGI]
timeFrame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
measure: Change from baseline in WHO Disability Assessment Schedule 2.0 [WHODAS 2.0]
timeFrame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
measure: Change from baseline in Simpson-Angus Scale [SAS]
timeFrame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
measure: Change from baseline in Clinician Rated Dimensions of Psychosis Symptom [CRDPS]
timeFrame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Other outcomes:
measure: Change from baseline in Letter-Number Span
timeFrame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
measure: Change from baseline in Wechsler Working Memory
timeFrame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
measure: Change from baseline in Resting-state functional MRI:TR=2000 ms，TE=35 ms，FA=90，Matrix =64×64，Nex=1，FOV=256 mm，thickness=4 mm，Gap=0,scanning 33 slices。
timeFrame: 2 times (Before treatment,immediately after treatment)
measure: Change from baseline in diffusion tensor imaging (DTI):TR=8500,TE=87, matrix size=64×64, FOV=230, slices thickness = 3 mm, diff directions=30,scanning 46 slices
timeFrame: 2 times (Before treatment,immediately after treatment)
measure: Change from baseline in Magnetic Resonance Spectroscopy (MRS) of DMPFC
timeFrame: 2 times (Before treatment,immediately after treatment)
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: