The Optimal Treatment for Treatment-resistant Schizophrenia

March 11, 2019 updated by: Shanghai Mental Health Center
The Optimal Treatment for Treatment-resistant Schizophrenia

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Risperidone with Clozapine
Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Other Names:
  • Risperidone Tablet
Active Comparator: 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
Drug: Aripiprazole with Clozapine
Aripiprazole may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Other Names:
  • Aripiprazole Tablets
Active Comparator: 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.
Drug: sodium valproate with Clozapine
sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Other Names:
  • Valproate
Active Comparator: clozapine
only clozapine, dosage and frequency:300~600 mg/d;
Device: clozapine
clozapine may be used in the treatment of treatment-resistant schizophrenia
Active Comparator: Modified electroconvulsive therapy 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.
Device: modified electroconvulsive therapy(MECT) with Clozapine
modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Active Comparator: Magnetic seizure therapy 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.
Device: Magnetic 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Positive and Negative Syndrome Scale [PANSS]
Time Frame: At baseline, 4th week, 8th week,12th week
At baseline, 4th week, 8th week,12th week

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in clinical global impression [CGI]
Time Frame: At baseline, 4th week, 8th week,12th week
At baseline, 4th week, 8th week,12th week
Change from baseline in Simpson-Angus Scale [SAS]
Time Frame: At baseline, 4th week, 8th week,12th week
At baseline, 4th week, 8th week,12th week
Change from baseline in Abnormal Involuntary Movement Scale[AIMS]
Time Frame: At baseline, 4th week, 8th week,12th week
At baseline, 4th week, 8th week,12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The optimal treatment for TRS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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