The Optimal Treatment for Treatment-resistant Schizophrenia

NCT ID: NCT02926976

Last Updated: 2019-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Optimal Treatment for Treatment-resistant Schizophrenia

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Risperidone with Clozapine

Intervention Type DRUG

Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia

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

Group Type ACTIVE_COMPARATOR

Aripiprazole with Clozapine

Intervention Type DRUG

Aripiprazole may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia

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.

Group Type ACTIVE_COMPARATOR

sodium valproate with Clozapine

Intervention Type DRUG

sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia

clozapine

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

Group Type ACTIVE_COMPARATOR

clozapine

Intervention Type DEVICE

clozapine may be used in the treatment of treatment-resistant schizophrenia

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.

Group Type ACTIVE_COMPARATOR

modified electroconvulsive therapy(MECT) with Clozapine

Intervention Type DEVICE

modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia

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.

Group Type ACTIVE_COMPARATOR

Magnetic seizure therapy(MST) with Clozapine

Intervention Type DEVICE

Magnetic seizure therapy(MST) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Risperidone with Clozapine

Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia

Intervention Type DRUG

Aripiprazole with Clozapine

Aripiprazole may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia

Intervention Type DRUG

sodium valproate with Clozapine

sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia

Intervention Type DRUG

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

Intervention Type 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

Intervention Type DEVICE

clozapine

clozapine may be used in the treatment of treatment-resistant schizophrenia

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Risperidone Tablet Aripiprazole Tablets Valproate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

DTliu

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dengtang Liu

Role: CONTACT

+86 21 64387250-73775

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

DT Liu, PHD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

The optimal treatment for TRS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.