SchizophreniaNCT02926976
The Optimal Treatment for Treatment-resistant Schizophrenia
A study testing Risperidone with Clozapine, Aripiprazole with Clozapine and sodium valproate with Clozapine in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The Optimal Treatment for Treatment-resistant Schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone with Clozapine, Aripiprazole with Clozapine and sodium valproate with Clozapine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The Optimal Treatment for Treatment-resistant Schizophrenia
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Risperidone with Clozapine, Aripiprazole with Clozapine, sodium valproate with Clozapine, modified electroconvulsive therapy(MECT) with Clozapine, Magnetic seizure therapy(MST) with Clozapine
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone with ClozapineDrug
Also called Risperidone Tablet
Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Aripiprazole with ClozapineDrug
Also called Aripiprazole Tablets
Aripiprazole may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
sodium valproate with ClozapineDrug
Also called Valproate
sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
modified electroconvulsive therapy(MECT) with ClozapineDevice
modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Magnetic seizure therapy(MST) with ClozapineDevice
Magnetic seizure therapy(MST) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
clozapineDevice
clozapine may be used in the treatment of treatment-resistant schizophrenia
| Study group | Role | What they receive |
|---|---|---|
| risperidone with clozapine | Active comparator | 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 Receives: Drug: Risperidone with Clozapine |
| aripiprazole with clozapine | Active comparator | aripiprazole, dosage form: 5 mg, dosage and frequency:15~30 mg/day; clozapine, dosage and frequency:300~600 mg/d; duration: 8 weeks Receives: Drug: Aripiprazole with Clozapine |
| sodium valproate with clozapine | Active comparator | sodium valproate, dosage form: 250 mg, dosage and frequency:600~1200 mg/day; clozapine, dosage and frequency:300~600 mg/d; duration: 3 months. Receives: Drug: sodium valproate with Clozapine |
| clozapine | Active comparator | only clozapine, dosage and frequency:300~600 mg/d; Receives: Device: clozapine |
| Modified electroconvulsive therapy with clozapine | Active comparator | 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. Receives: Device: modified electroconvulsive therapy(MECT) with Clozapine |
| Magnetic seizure therapy with clozapine | Active comparator | 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. Receives: Device: Magnetic seizure therapy(MST) with Clozapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Positive and Negative Syndrome Scale [PANSS]
Measured: At baseline, 4th week, 8th week,12th week
Secondary outcomes (3)
Change from baseline in clinical global impression [CGI]
Measured: At baseline, 4th week, 8th week,12th week
Change from baseline in Simpson-Angus Scale [SAS]
Measured: At baseline, 4th week, 8th week,12th week
Change from baseline in Abnormal Involuntary Movement Scale[AIMS]
Measured: At baseline, 4th week, 8th week,12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926976
- Sponsor's protocol ID
- The optimal treatment for TRS
- Status last verified
- Oct 2017
- First submitted
- 5 Oct 2016
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Treatment for Treatment-resistant Schizophrenia
- ClinicalTrials.gov ID
- NCT02926976
- Acronym / sponsor ID
- The optimal treatment for TRS
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| risperidone with clozapine | Active comparator | Drug: Risperidone with Clozapinerisperidone, 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 comparator | Drug: Aripiprazole with Clozapinearipiprazole, 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 comparator | Drug: sodium valproate with Clozapinesodium 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 comparator | Device: clozapineonly clozapine, dosage and frequency:300~600 mg/d; |
| Modified electroconvulsive therapy with clozapine | Active comparator | Device: modified electroconvulsive therapy(MECT) with Clozapine10 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 comparator | Device: Magnetic seizure therapy(MST) with Clozapine10 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidone with ClozapineAlso: Risperidone TabletRisperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia | Drug | risperidone with clozapine |
| Aripiprazole with ClozapineAlso: Aripiprazole TabletsAripiprazole may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia | Drug | aripiprazole with clozapine |
| sodium valproate with ClozapineAlso: Valproatesodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia | Drug | sodium valproate with clozapine |
| modified electroconvulsive therapy(MECT) with Clozapinemodified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia | Device | Modified electroconvulsive therapy with clozapine |
| Magnetic seizure therapy(MST) with ClozapineMagnetic seizure therapy(MST) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia | Device | Magnetic seizure therapy with clozapine |
| clozapineclozapine may be used in the treatment of treatment-resistant schizophrenia | Device | clozapine |
Primary outcome
Change from baseline in Positive and Negative Syndrome Scale [PANSS]
Time frame: At baseline, 4th week, 8th week,12th week
3 secondary outcomes
Change from baseline in clinical global impression [CGI]
Time frame: 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
Change from baseline in Abnormal Involuntary Movement Scale[AIMS]
Time frame: At baseline, 4th week, 8th week,12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risperidone with Clozapine, Aripiprazole with Clozapine and sodium valproate with Clozapine in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dengtang Liu (+86 21 64387250-73775, erliu110@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Positive and Negative Syndrome Scale [PANSS] (time frame: At baseline, 4th week, 8th week,12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.