NCT07918222RecruitingPhase 3
Sequential Treatment Approaches for Treatment-Resistant Schizophrenia
Sequential Treatment Approaches for Treatment-Resistant Schizophrenia (STATRS): A Randomized Controlled Trial of Pharmacological Optimization and Neuromodulation in Chinese Patients
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 14 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Dec 2030
- Lead sponsor
- Shanghai Mental Health Center
- Diseases
- Schizophrenia
- NCT number
- NCT07918222
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 1 Sept 2026 to the primary completion date, 1 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Intellectual disability or Mental retardation.
- Pregnancy, breastfeeding, or planning pregnancy during the study period.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.