Step-by-step drug and brain stimulation treatments for schizophrenia that has not responded to medicine
Compares clozapine-based drug treatment with two brain stimulation therapies in adults with treatment-resistant schizophrenia.
Plain-language title generated from the registry record
Registry title: Sequential Treatment Approaches for Treatment-Resistant Schizophrenia
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT07918222, who can take part
Where in China
- Shanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Mental Health Center
- Trial code
- NCT07918222
- Record updated
- 5 November 2026
- Original description
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:Read full original descriptionShow less
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.
Inclusion: 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; 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.
Exclusion: 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; Severe physical illness or medical contraindication to study medication, MECT, MST; Extreme agitation, stupor, active suicidal risk, severe non-cooperation, or high-risk conditions; Intellectual disability or Mental retardation; Pregnancy, breastfeeding, or planning pregnancy during the study period.