The Optimal Treatment for Treatment-resistant Schizophrenia

Not Applicable

• Conditions: Schizophrenia
• Interventions: Drug: Aripiprazole with Clozapine; Drug: sodium valproate with Clozapine; Device: clozapine; Device: Magnetic seizure therapy(MST) with Clozapine; Drug: Risperidone with Clozapine; Device: modified electroconvulsive therapy(MECT) with Clozapine

• Registration Number: NCT02926976
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Study Start: 2016-11
• Status Verified: 2017-10
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aripiprazole with clozapine	Aripiprazole with Clozapine	aripiprazole, dosage form: 5 mg, dosage and frequency:15\~30 mg/day; clozapine, dosage and frequency:300\~600 mg/d; duration: 8 weeks
sodium valproate with clozapine	sodium valproate with Clozapine	sodium valproate, dosage form: 250 mg, dosage and frequency:600\~1200 mg/day; clozapine, dosage and frequency:300\~600 mg/d; duration: 3 months.
clozapine	clozapine	only clozapine, dosage and frequency:300\~600 mg/d;
Magnetic seizure therapy with clozapine	Magnetic seizure therapy(MST) with Clozapine	10 times MST for 4 weeks, if the PANSS reductive ratio is less 20% in the end of 8th week by the using of risperidone with clozapine, aripiprazole with clozapine, sodium valproate with clozapine, or clozapine.
risperidone with clozapine	Risperidone with Clozapine	risperidone, dosage form: 1 mg, dosage and frequency:3.0\~6.0 mg/d; clozapine, dosage and frequency:300\~600 mg/d; duration: 8 weeks
Modified electroconvulsive therapy with clozapine	modified electroconvulsive therapy(MECT) with Clozapine	10 times MECT for 4 weeks, if the PANSS reductive ratio is less 20% in the end of 8th week by the using of risperidone with clozapine, aripiprazole with clozapine, sodium valproate with clozapine, or clozapine.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Positive and Negative Syndrome Scale [PANSS]	At baseline, 4th week, 8th week,12th week

Secondary Outcome Measures

Name	Time	Method
Change from baseline in clinical global impression [CGI]	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
Change from baseline in Simpson-Angus Scale [SAS]	At baseline, 4th week, 8th week,12th week

Trial Locations

Locations (1)

DTliu; 🇨🇳 Shanghai, China