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The Optimal Treatment for Treatment-resistant Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Risperidone with Clozapine
Aripiprazole with Clozapine
sodium valproate with Clozapine
modified electroconvulsive therapy(MECT) with Clozapine
Magnetic seizure therapy(MST) with Clozapine
clozapine
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • DTliuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

risperidone with clozapine

aripiprazole with clozapine

sodium valproate with clozapine

clozapine

Modified electroconvulsive therapy with clozapine

Magnetic seizure therapy with clozapine

Arm 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

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

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

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in Positive and Negative Syndrome Scale [PANSS]

Secondary Outcome Measures

Change from baseline in clinical global impression [CGI]
Change from baseline in Simpson-Angus Scale [SAS]
Change from baseline in Abnormal Involuntary Movement Scale[AIMS]

Full Information

First Posted
October 5, 2016
Last Updated
March 11, 2019
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT02926976
Brief Title
The Optimal Treatment for Treatment-resistant Schizophrenia
Official Title
The Optimal Treatment for Treatment-resistant Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
risperidone with clozapine
Arm Type
Active Comparator
Arm 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
Arm Title
aripiprazole with clozapine
Arm Type
Active Comparator
Arm Description
aripiprazole, dosage form: 5 mg, dosage and frequency:15~30 mg/day; clozapine, dosage and frequency:300~600 mg/d; duration: 8 weeks
Arm Title
sodium valproate with clozapine
Arm Type
Active Comparator
Arm 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.
Arm Title
clozapine
Arm Type
Active Comparator
Arm Description
only clozapine, dosage and frequency:300~600 mg/d;
Arm Title
Modified electroconvulsive therapy with clozapine
Arm Type
Active Comparator
Arm 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.
Arm Title
Magnetic seizure therapy with clozapine
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Risperidone with Clozapine
Other Intervention Name(s)
Risperidone Tablet
Intervention Description
Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Intervention Type
Drug
Intervention Name(s)
Aripiprazole with Clozapine
Other Intervention Name(s)
Aripiprazole Tablets
Intervention Description
Aripiprazole may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Intervention Type
Drug
Intervention Name(s)
sodium valproate with Clozapine
Other Intervention Name(s)
Valproate
Intervention Description
sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Intervention Type
Device
Intervention Name(s)
modified electroconvulsive therapy(MECT) with Clozapine
Intervention Description
modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Intervention Type
Device
Intervention Name(s)
Magnetic seizure therapy(MST) with Clozapine
Intervention Description
Magnetic seizure therapy(MST) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Intervention Type
Device
Intervention Name(s)
clozapine
Intervention Description
clozapine may be used in the treatment of treatment-resistant schizophrenia
Primary Outcome Measure Information:
Title
Change from baseline in Positive and Negative Syndrome Scale [PANSS]
Time Frame
At baseline, 4th week, 8th week,12th week
Secondary Outcome Measure Information:
Title
Change from baseline in clinical global impression [CGI]
Time Frame
At baseline, 4th week, 8th week,12th week
Title
Change from baseline in Simpson-Angus Scale [SAS]
Time Frame
At baseline, 4th week, 8th week,12th week
Title
Change from baseline in Abnormal Involuntary Movement Scale[AIMS]
Time Frame
At baseline, 4th week, 8th week,12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dengtang Liu
Phone
+86 21 64387250-73775
Email
erliu110@126.com
Facility Information:
Facility Name
DTliu
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DT Liu, PHD
Email
erliu110@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Optimal Treatment for Treatment-resistant Schizophrenia

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