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Treatment-resistant SchizophreniaPhase 3STATRSNCT07918222

Sequential Treatment Approaches for Treatment-Resistant Schizophrenia

A Phase 3 study testing [Phase 1] Clozapine, [Phase 1] Aripiprazole and [Phase 1] Amisulpride in people with Treatment-resistant Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this study is to optimize treatment strategies for Chinese patients with treatment-resistant schizophrenia (TRS). It will compare two types of treatment: 1. Drug therapy with clozapine alone or in combination with other medications. 2. 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?
[Phase 1] Clozapine, [Phase 1] Aripiprazole and [Phase 1] Amisulpride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
1 Sep 2026to 1 Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • General inclusion criteria applicable to all participants:
  • Aged 18 to 55 years at the time of informed consent.
  • Participants must meet DSM-5 diagnostic criteria for schizophrenia.
  • Meet TRRIP-based criteria for treatment-resistant schizophrenia, defined as inadequate response to at least two different antipsychotic treatment trials, each administered at an adequate dose equivalent to ≥600 mg/day chlorpromazine for a minimum duration of 6 weeks. Have moderate or greater functional impairment, operationalized as a Personal and Social Performance Scale (PSP) score ≤70. Treatment adherence will be evaluated based on available medical records, prescription history and caregiver report.
  • Eligibility for the pharmacological optimization phase:
  • Participants eligible for the pharmacological optimization phase must meet the general TRS criteria above and must be clozapine-naive.
Show all 11Show fewer
  • Eligibility for the neuromodulation phase:
  • Participants eligible for the neuromodulation phase must meet the TRS criteria described above.
  • Participants may enter the neuromodulation phase through either of the following pathways:
  • Participants who have previously received clozapine treatment and are hospitalized due to symptom exacerbation or clinical worsening.
  • Clozapine-naive TRS participants who complete the pharmacological optimization phase and show inadequate response, defined as less than 25% reduction in PANSS total score at Week 8.

Who cannot join

  • Organic brain disease or neurological disorder that may account for psychotic symptoms, including epilepsy where clinically relevant.
  • Current psychoactive substance dependence or substance-related disorder.
  • Intellectual disability or Mental retardation.
  • Pregnancy, breastfeeding, or planning pregnancy during the study period.
  • Severe physical illness or medical contraindication to study medication, MECT, MST.
  • Extreme agitation, stupor, active suicidal risk, severe non-cooperation, or high-risk conditions.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

DengTang Liu, MD, PhD contact

+86-18017311138

erliu110@126.com

China1 site, 1 recruiting

  • Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200030

    DengTang Liu, MD, PhD, +862164387250-73775, erliu110@126.com

    Recruiting

Other trials in China

About this study

Official title: Sequential Treatment Approaches for Treatment-Resistant Schizophrenia (STATRS): A Randomized Controlled Trial of Pharmacological Optimization and Neuromodulation in Chinese Patients

The goal of this study is to optimize treatment strategies for Chinese patients with treatment-resistant schizophrenia (TRS). It will compare two types of treatment:

  1. Drug therapy with clozapine alone or in combination with other medications.
  2. Neuromodulation therapy, modified electroconvulsive therapy (MECT) or magnetic seizure therapy (MST).

The study aims to determine which approach provides better symptom improvement, fewer cognitive side effects, and greater overall safety. The results may provide important clinical evidence to guide future treatment decisions for patients with TRS.

Read the detailed description

This is a sequential, assessor-blinded randomized controlled trial in Chinese patients with treatment-resistant schizophrenia (TRS). The study consists of two treatment components.

First, clozapine-naive TRS participants will enter an 8-week pharmacological optimization phase and be assigned to one of three treatment groups: clozapine monotherapy, clozapine plus amisulpride, or clozapine plus aripiprazole.

Second, eligible participants will enter a 4-week assessor-blinded neuromodulation phase comparing modified electroconvulsive therapy (MECT) and magnetic seizure therapy (MST). Participants for this phase are either (1) patients who have previously received clozapine and are hospitalized due to symptom exacerbation, or (2) participants who completed the pharmacological optimization phase and showed inadequate response, defined as less than 25% reduction in PANSS total score at Week 8.

The study is expected to provide evidence on the effectiveness, cognitive safety, and overall tolerability of these treatments for TRS. The project has important clinical significance.

Being tested
[Phase 1] Clozapine, [Phase 1] Aripiprazole, [Phase 1] Amisulpride, [Phase 2] Modified Electroconvulsive Therapy (MECT), [Phase 2] Magnetic Seizure Therapy (MST)
Keywords
Tratment-resistant schizophrenia, Clozapine combination therapy, Neuromodulation
Medical subject headings
Schizophrenia, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [Phase 1] ClozapineDrug

    Also called Clo

    Initial dose: 25-50 mg/day orally. Clozapine will be individually titrated over 8 weeks, with a usual target dose of 300-450 mg/day and a target steady-state trough plasma concentration of ≥350 ng/mL. Plasma clozapine concentration will be assessed at Week 4.

    If the concentration is <350 ng/mL, the dose will be further increased as clinically tolerated. A dose of ≥300 mg/day is not required if the target plasma concentration is achieved at a lower dose. Participants who cannot reach either 300 mg/day or the target plasma concentration because of intolerance may remain on their maximum tolerated dose below 300 mg/day.

  • [Phase 1] AripiprazoleDrug

    Also called Ari

    Initial dose: 5-10 mg/day. Aripiprazole recommended dosage:10-15 mg/day. dosage form:po.duration:8 weeks

  • [Phase 1] AmisulprideDrug

    Also called Ami

    Initial dose: 200-400 mg/day. Amisulpride recommended dosage: 400-800 mg/day. dosage form:po.duration:8 weeks

  • [Phase 2] Modified Electroconvulsive Therapy (MECT)Device

    Also called MECT

    MECT will be administered using a Thymatron System IV device. The electrical charge will be determined according to the participant's age and body weight, with treatment parameters adjusted according to the study protocol and clinical response. Participants will continue the pharmacotherapy regimen received before Phase 2. Medication doses will remain stable whenever clinically feasible; changes will be permitted only when clinically necessary for safety or tolerability and will be documented.

  • [Phase 2] Magnetic Seizure Therapy (MST)Device

    Also called MST

    MST will be administered using a MagPro X100 magnetic stimulator equipped with the MagOption MST module. The stimulation frequency will be set at 100 Hz and output intensity at 100% of device output. Stimulation duration will be titrated according to the study protocol and individual participant response. Participants will continue the pharmacotherapy regimen received before Phase 2. Medication doses will remain stable whenever clinically feasible; changes will be permitted only when clinically necessary for safety or tolerability and will be documented.

Study groups in NCT07918222
Study groupRoleWhat they receive
[Phase 1] Clozapine MonotherapyActive comparatorPhase 1 of the trial is an 8-week randomized controlled trial(RCT); patients will be randomly assigned to one of three treatment arms with different oral antipsychotics, one is Clozapine Monotherapy. Non-responders in phase 1 will switch to phase 2.
Receives: Drug: [Phase 1] Clozapine
[Phase 1] Clozapine + AripiprazoleExperimentalPhase 1 of the trial is a 8-week randomized controlled trial(RCT); patients will be randomly assigned to one of three treatment arms with different oral antipsychotics, one of which is 'Clozapine + Aripiprazole'. Non-responders in phase 1 will switch to phase 2.
Receives: Drug: [Phase 1] Clozapine; Drug: [Phase 1] Aripiprazole
[Phase 1] Clozapine + AmisulprideExperimentalPhase 1 of the trial is a 8-week randomized controlled trial(RCT); patients will be randomly assigned to one of three treatment arms with different oral antipsychotics, one of which is 'Clozapine + Amisulpride'. Non-responders in phase 1 will switch to phase 2.
Receives: Drug: [Phase 1] Clozapine; Drug: [Phase 1] Amisulpride
[Phase 2] Modified Electroconvulsive Therapy (MECT)Active comparatorCRS participants will receive modified electroconvulsive therapy while maintaining stable pharmacological treatment. The treatment course consists of 3 times per week for the first two weeks, followed by 2 times per week for the next two weeks, totaling 10 times per month, which is the same number of treatment sessions as the MST group.
Receives: Device: [Phase 2] Modified Electroconvulsive Therapy (MECT)
[Phase 2] Magnetic Seizure Therapy (MST)ExperimentalCRS participants will receive magnetic seizure therapy while maintaining stable pharmacological treatment. The treatment course consists of 3 times per week for the first two weeks, followed by 2 times per week for the next two weeks, totaling 10 times per month, which is the same number of treatment sessions as the MECT group.
Receives: Device: [Phase 2] Magnetic Seizure Therapy (MST)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PANSS reduction rate at Week 8 during the pharmacological optimization phase

    Percentage reduction in Positive and Negative Syndrome Scale total score from baseline to Week 8. The PANSS scale consists of 30 items, and each item is rated on a 7-point scale, ranging from 1 (no symptoms) to 7 (extremely severe). The PANSS reduction rate is calculated as: (baseline PANSS total score - Week 8 PANSS total score) / (baseline PANSS total score - 30) × 100%.

    Measured: Baseline of pharmacological optimization phase and Week 8

  2. PANSS reduction rate at Week 4 during the neuromodulation phase

    Percentage reduction in PANSS total score from baseline of the neuromodulation phase to Week 4. The PANSS scale consists of 30 items, and each item is rated on a 7-point scale, ranging from 1 (no symptoms) to 7 (extremely severe). The PANSS reduction rate is calculated as: (baseline PANSS total score - Week 4 PANSS total score) / (baseline PANSS total score - 30) × 100%.

    Measured: Baseline of neuromodulation phase and Week 4

Secondary outcomes (10)

  1. Change in CGI-S score

    Change in Clinical Global Impression-Severity (CGI-S) score from baseline to the end of assigned treatment. The scale provides an assessment of both disease severity and overall efficacy.The severity of the disease was scored on an eight-point scale ranging from 0 (not rated) to 7 (extremely severe). The overall efficacy was assessed on an 8-point scale ranging from 0 (not assessed) to 7 (significant deterioration).

    Measured: Pharmacological optimization: baseline and Week 8; Neuromodulation: baseline and Week 4.

  2. Trajectory of PANSS total score improvement during the neuromodulation phase

    Rate of change in Positive and Negative Syndrome Scale total score during the 4-week neuromodulation treatment course. The PANSS scale consists of 30 items, and each item is rated on a 7-point scale, ranging from 1 (no symptoms) to 7 (extremely severe). Repeated PANSS assessments will be used to compare the trajectory and speed of symptom improvement between the MECT and MST groups.

    Measured: Baseline of the neuromodulation phase and weekly during the 4-week neuromodulation treatment course

  3. Change in AMT specificity score during the neuromodulation phase

    Change in Autobiographical Memory Test(AMT) specificity score from baseline of the neuromodulation phase to Week 4. The AMT specificity score is defined as the number of specific autobiographical memories retrieved in response to 12 cue words, with scores ranging from 0 to 12 and higher scores indicating better autobiographical memory specificity. Change is calculated as Week 4 AMT specificity score minus baseline AMT specificity score; negative values indicate decline in autobiographical memory specificity.

    Measured: Baseline of the neuromodulation phase and Week 4

  4. Change from baseline in cognitive function: MCCB

    MATRICS consensus cognitive battery (MCCB) consists of 10 tests that assess cognitive performance in 7 domains, including processing speed, attention/vigilance, working memory, verbal memory, visual learning, reasoning and problem solving, and social cognition.The MCCB T-score is calculated based on a Chinese community sample, with a normative mean of 50 and a standard deviation of 10. Higher scores indicate a better neurocognitive outcome.

    Measured: Baseline, Month 1, and Month 2 during the pharmacological optimization phase; and Week 4 of the neuromodulation phase.

  5. Change in visuospatial working memory during the neuromodulation phase

    Change in visuospatial working memory from baseline to Week 4, assessed using the Wechsler Memory Scale-III Spatial Span subtest (WMS III). The WMS III total score ranges from 0 to 32, with higher scores indicating better visuospatial working memory performance.

    Measured: Baseline of the neuromodulation phase and weekly during the 4-week neuromodulation phase

  6. Change in visual learning during the neuromodulation phase

    Change in visual learning from baseline to Week 4, assessed using the Brief Visuospatial Memory Test-Revised (BVMT-R).The BVMT-R total recall score ranges from 0 to 36, where higher scores indicate better visual learning ability.

    Measured: Baseline of the neuromodulation phase and weekly during the 4-week neuromodulation phase

  7. Change in personal and social functioning

    Change in Personal and Social Performance Scale(PSP) score from baseline to the end of the corresponding treatment phase.The PSP score ranges from 0 to 100, where higher scores indicate better personal and social functioning.

    Measured: Baseline, Week 8 of the pharmacological optimization phase and Week 4 of the neuromodulation phase

  8. Extrapyramidal adverse effects: The Barnes Akathisia Scale (BAS)

    The Barnes Akathisia Scale (BAS) will be used to evaluate objective performance and subjective experience of akathisia, scored from 0 to 3, and the overall clinical evaluation of akathisia is scored from 0 to 5. The higher scores mean a more serious side effect.

    Measured: Baseline, Week 4, Week 8 during the pharmacological optimization phase and Week 1, Week 2, Week 3, Week 4 during the neuromodulation phase

  9. Extrapyramidal adverse effects: Simpson-Angus Extrapyramidal Side Effects Scale (SAS)

    Simpson-Angus Extrapyramidal Side Effects Scale (SAS) consists of 10 items, each scored from 0 to 4. The higher scores mean a more serious side effect.

    Measured: Baseline, Week 4, Week 8 during the pharmacological optimization phase and Week 1, Week 2, Week 3, Week 4 during the neuromodulation phase

  10. Extrapyramidal adverse effects: Abnormal Involuntary Movement Scale (AIMS)

    Abnormal Involuntary Movement Scale (AIMS) consists of 12 items. The first 10 of 12 items is scored from 0 to 4, and the last 2 is scored from 0 to 1. The higher scores mean the more obvious abnormal involuntary movement.

    Measured: Baseline, Week 4, Week 8 during the pharmacological optimization phase and Week 1, Week 2, Week 3, Week 4 during the neuromodulation phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start1 Sep 2026
  3. Primary completion1 Dec 2030 (estimated)
  4. Study completion1 Dec 2030 (estimated)

Resources

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
Model description
A sequential design will be used. In Phase 1, clozapine-naive TRS participants will be randomized to clozapine monotherapy, clozapine plus aripiprazole, or clozapine plus amisulpride for 8 weeks. In Phase 2, eligible participants will be randomized to MECT or MST for a 4-week neuromodulation phase.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07918222
Sponsor's protocol ID
2025-SFDL01
Acronym
STATRS
Status last verified
Oct 2026
First submitted
14 Jul 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because the study involves sensitive clinical, cognitive, imaging, and biological data from patients with schizophrenia, and data sharing is limited by participant consent and institutional ethics requirements. Only aggregate study results will be reported.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing [Phase 1] Clozapine, [Phase 1] Aripiprazole and [Phase 1] Amisulpride 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 11 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact DengTang Liu, MD, PhD (+86-18017311138, erliu110@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PANSS reduction rate at Week 8 during the pharmacological optimization phase (time frame: Baseline of pharmacological optimization phase and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07918222.

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 5 Nov 2026.

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