The Optimal Treatment for Treatment-resistant Schizophrenia

Shanghai Mental Health Center

Status: Unknown

Conditions: Schizophrenia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02926976

The optimal treatment for TRS

Details and patient eligibility

About

The Optimal Treatment for Treatment-resistant Schizophrenia

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

150 participants in 6 patient groups

risperidone with clozapine

Active Comparator group

Description:

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

Treatment:

Drug: Risperidone with Clozapine

aripiprazole with clozapine

Active Comparator group

Description:

aripiprazole, dosage form: 5 mg, dosage and frequency:15\~30 mg/day; clozapine, dosage and frequency:300\~600 mg/d; duration: 8 weeks

Treatment:

Drug: Aripiprazole with Clozapine

sodium valproate with clozapine

Active Comparator group

Description:

sodium valproate, dosage form: 250 mg, dosage and frequency:600\~1200 mg/day; clozapine, dosage and frequency:300\~600 mg/d; duration: 3 months.

Treatment:

Drug: sodium valproate with Clozapine

clozapine

Active Comparator group

Description:

only clozapine, dosage and frequency:300\~600 mg/d;

Treatment:

Device: clozapine

Modified electroconvulsive therapy with clozapine

Active Comparator group

Description:

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.

Treatment:

Device: modified electroconvulsive therapy(MECT) with Clozapine

Magnetic seizure therapy with clozapine

Active Comparator group

Description:

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.

Treatment:

Device: Magnetic seizure therapy(MST) with Clozapine