Treatment-resistant SchizophreniaPhase 3NCT04528095
SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
A Phase 3 study testing Clozapine, MECT and DBS in people with Treatment-resistant Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The project intends to take treatment-resistant schizophrenia as the research object and uses sequential multiple assignment randomized trial(SMART) design to define the treatment recommendations of different drug regimen for treatment resistant schizophrenia and to determine the physical enhancement regimen for… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Treatment-resistant Schizophrenia
- What is being tested?
- Clozapine, MECT and DBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- Dec 2020to Dec 2022
- Phase
- Phase 3
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- meet the DSM-5 diagnostic criteria for schizophrenia,
- be 18-55 years of age,
- treatment-resistant schizophrenia:no response to sufficient doses (400-600 mg/ day CPZ equivalent) of at least two antipsychotics in the past 5 years,
- Informed consent.
Who cannot join
- Patients with medical or psychiatric comorbidities and those who require concomitant other medications are excluded.
- Patients with contraindications to even one of the proposed treatment arms are excluded.
- Patients with risks such as extreme agitation, stupor or suicide are excluded.
- Female patients with pregnancy or breast-feeding are also excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
The project intends to take treatment-resistant schizophrenia as the research object and uses sequential multiple assignment randomized trial(SMART) design to define the treatment recommendations of different drug regimen for treatment resistant schizophrenia and to determine the physical enhancement regimen for clozapine-resistant schizophrenia and to explore targeted regulation scheme for ultra-resistant schizophrenia.
Read the detailed description
This trial is a sequential multiple-assignment RCT design of antipsychotic drugs, planning to recruit 162 people with treatment-resistant schizophrenia followed for 12 months. The study includes three treatment phases and a naturalistic follow-up phase. Participants who meet the response criteria remain on that treatment for the duration of 12-month treatment. If the participants fail the treatment or can't tolerant the side effects, the patient moves to the next phase of the study to receive a new treatment.
- Conditions
- Treatment-resistant Schizophrenia
- Being tested
- Clozapine, MECT, DBS
- Keywords
- Schizophrenia, Treatment-resistant, Antipsychotics, Combination
- Medical subject headings
- Schizophrenia, Treatment-Resistant, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClozapineDrug
Also called Clozapine+Amisulpride, Clozapine+Gingke biloba
Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d
MECTDevice
Also called MST
MECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total
DBSDevice
Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)
| Study group | Role | What they receive |
|---|---|---|
| Clozapine | Experimental | Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Receives: Drug: Clozapine |
| Clozapine+Amisulpride | Experimental | Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d Receives: Drug: Clozapine |
| Clozapine+Gingke biloba | Experimental | Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Gingke biloba 120-360mg/d Receives: Drug: Clozapine |
| MECT | Experimental | MECT:The treatment lasted for 4 months,16 times in total Receives: Device: MECT |
| MST | Experimental | MST:The treatment lasted for 4 months,16 times in total Receives: Device: MECT |
| DBS | Experimental | Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively) Receives: Device: DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
25% or greater change in Positive and Negative Syndrome Scale (PANSS)
Measured: Change from baseline PANSS score at 12 weeks
Secondary outcomes (9)
Adverse reactions
The Barnes Akathisia Scale (BAS) (0,14,higher scores mean a worse outcome),
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Adverse reactions
Simpson-Angus Extrapyramidal Side Effects Scale (SAS) (0,40,higher scores mean a worse outcome)
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Adverse reactions
Abnormal Involuntary Movement Scale (AIMS) (0,42,higher scores mean a worse outcome)
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Neurocognitive assessments and social function
The University of California, San Diego (UCSD) Performance- based Skills Assessment-Brief (UPSA-B) (0,100,higher scores mean a better outcome) is used to evaluate the social function,
Measured: baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
Neurocognitive assessments and social function
The MATRICS consensus cognitive battery (MCCB) has been widely used to evaluate cognitive deficits in schizophrenia patients(0%,100%,higher scores mean a better outcome)
Measured: baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
Clinical assessements
PANSS (30,210,higher scores mean a worse outcome),
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Clinical assessements
Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPS) (0,32,higher scores mean a worse outcome),
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Clinical assessements
Calgary Depression Scale for Schizophrenia (CDSS) (0,27,higher scores mean a worse outcome)
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Clinical assessements
Clinical Global Impression Scale-Severity (CGI-S) (0,7,higher scores mean a worse outcome)
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-resistant 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dengtang Liu, MD, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528095
- Sponsor's protocol ID
- TRS-SMART
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
- ClinicalTrials.gov ID
- NCT04528095
- Acronym / sponsor ID
- TRS-SMART
- Conditions
- Treatment-resistant Schizophrenia
- Keywords
- Schizophrenia, Treatment-resistant, Antipsychotics, Combination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Aug 2020 (actual)
- 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 project intends to take treatment-resistant schizophrenia as the research object and uses sequential multiple assignment randomized trial(SMART) design to define the treatment recommendations of different drug regimen for treatment resistant schizophrenia and to determine the physical enhancement regimen for clozapine-resistant schizophrenia and to explore targeted regulation scheme for ultra-resistant schizophrenia.
Detailed description
This trial is a sequential multiple-assignment RCT design of antipsychotic drugs, planning to recruit 162 people with treatment-resistant schizophrenia followed for 12 months. The study includes three treatment phases and a naturalistic follow-up phase. Participants who meet the response criteria remain on that treatment for the duration of 12-month treatment. If the participants fail the treatment or can't tolerant the side effects, the patient moves to the next phase of the study to receive a new treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Clozapine | Experimental | Drug: ClozapineClozapine 400 ~ 600mg/d or plasma concentration >350ng/ml |
| Clozapine+Amisulpride | Experimental | Drug: ClozapineClozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d |
| Clozapine+Gingke biloba | Experimental | Drug: ClozapineClozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Gingke biloba 120-360mg/d |
| MECT | Experimental | Device: MECTMECT:The treatment lasted for 4 months,16 times in total |
| MST | Experimental | Device: MECTMST:The treatment lasted for 4 months,16 times in total |
| DBS | Experimental | Device: DBSTwo electrode emplacement groups (target nucleus accumbens and hippocampus respectively) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- meet the DSM-5 diagnostic criteria for schizophrenia,
- be 18-55 years of age,
- treatment-resistant schizophrenia:no response to sufficient doses (400-600 mg/ day CPZ equivalent) of at least two antipsychotics in the past 5 years,
- Informed consent.
Key exclusion criteria (4 listed)
- Patients with medical or psychiatric comorbidities and those who require concomitant other medications are excluded.
- Patients with contraindications to even one of the proposed treatment arms are excluded.
- Patients with risks such as extreme agitation, stupor or suicide are excluded.
- Female patients with pregnancy or breast-feeding are also excluded.
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 |
|---|---|---|
| ClozapineAlso: Clozapine+Amisulpride, Clozapine+Gingke bilobaClozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d | Drug | Clozapine, Clozapine+Amisulpride, Clozapine+Gingke biloba |
| MECTAlso: MSTMECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total | Device | MECT, MST |
| DBSTwo electrode emplacement groups (target nucleus accumbens and hippocampus respectively) | Device | DBS |
Primary outcome
Response rate
Time frame: Change from baseline PANSS score at 12 weeks
25% or greater change in Positive and Negative Syndrome Scale (PANSS)
9 secondary outcomes
Adverse reactions
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Adverse reactions
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Adverse reactions
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Neurocognitive assessments and social function
Time frame: baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
Neurocognitive assessments and social function
Time frame: baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
Clinical assessements
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Clinical assessements
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Clinical assessements
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Clinical assessements
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
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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.
Dengtang Liu, MD study chair
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clozapine, MECT and DBS in people with Treatment-resistant 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 4 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 27 Aug 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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, MD (18017311138, erliu110@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Change from baseline PANSS score at 12 weeks). 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 27 Aug 2020.