The Optimal Treatment for Treatment-resistant Schizophrenia
1 other identifier
interventional
150
1 country
1
Brief Summary
The Optimal Treatment for Treatment-resistant Schizophrenia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2016
CompletedFirst Posted
Study publicly available on registry
October 6, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMarch 13, 2019
October 1, 2017
2.8 years
October 5, 2016
March 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Positive and Negative Syndrome Scale [PANSS]
At baseline, 4th week, 8th week,12th week
Secondary Outcomes (3)
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
Study Arms (6)
risperidone with clozapine
ACTIVE COMPARATORrisperidone, 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 with clozapine
ACTIVE COMPARATORaripiprazole, 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
ACTIVE COMPARATORsodium valproate, dosage form: 250 mg, dosage and frequency:600\~1200 mg/day; clozapine, dosage and frequency:300\~600 mg/d; duration: 3 months.
clozapine
ACTIVE COMPARATORonly clozapine, dosage and frequency:300\~600 mg/d;
Modified electroconvulsive therapy with clozapine
ACTIVE COMPARATOR10 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.
Magnetic seizure therapy with clozapine
ACTIVE COMPARATOR10 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.
Interventions
Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
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
Magnetic seizure therapy(MST) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Eligibility Criteria
You may qualify if:
- The diagnosis of schizophrenia according to DSM-V
- ～60 years old
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
DTliu
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2016
First Posted
October 6, 2016
Study Start
November 1, 2016
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
March 13, 2019
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share