Schizophrenia
Conditions
Keywords
Schizophrenia
Brief summary
The Optimal Treatment for Treatment-resistant Schizophrenia
Detailed description
To explore the curative effect and safety of Risperidone，aripiprazole，sodium valproate，modified electroconvulsive therapy(MECT), or Magnetic seizure therapy(MST) with Clozapine in the treatment of treatment-resistant schizophrenia， and to provide the basis for clinical medication.
Interventions
DRUGRisperidone with Clozapine
Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
DRUGAripiprazole with Clozapine
Aripiprazole may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
DEVICEMagnetic seizure therapy(MST) with Clozapine
Magnetic seizure therapy(MST) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
DEVICEclozapine
clozapine may be used in the treatment of treatment-resistant schizophrenia
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* The diagnosis of schizophrenia according to DSM-V * 18～60 years old * 2 prior failed treatment trials with 2 different antipsychotics at doses of at least 600 mg/day chlorpromazine equivalents, each of at least 6 weeks duration; * Signed an informed consent
Exclusion criteria
* patients to be diagnosed according to DSM-V for substance abused, development delayed * suffering from serious physical disease and can not accept the treatment * MST contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure * allergic to risperidone ,aripiprazole, or sodium valproate * Participated in any clinical subject within 30 days * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Positive and Negative Syndrome Scale [PANSS] | At baseline, 4th week, 8th week,12th week |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in clinical global impression [CGI] | At baseline, 4th week, 8th week,12th week |
| Change from baseline in Simpson-Angus Scale [SAS] | At baseline, 4th week, 8th week,12th week |
| Change from baseline in Abnormal Involuntary Movement Scale[AIMS] | At baseline, 4th week, 8th week,12th week |
Countries
China
Contacts
Primary ContactDengtang Liu
Outcome results
None listed