- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02926976
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
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
-
-
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Shanghai, China
- Recruiting
- DTliu
-
Contact:
- DT Liu, PHD
- Email: erliu110@126.com
-
-
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
16 years to 58 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
|
Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Other Names:
|
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
|
Aripiprazole may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Other Names:
|
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.
|
sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Other Names:
|
Active Comparator: clozapine
only clozapine, dosage and frequency:300~600 mg/d;
|
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.
|
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.
|
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
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
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- GABA Antagonists
- Aripiprazole
- Valproic Acid
- Risperidone
- Clozapine
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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