Sequential Treatment Approaches for Treatment-Resistant Schizophrenia in Chinese Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 3, assessor-blinded study conducted in Shanghai, participants with treatment-resistant schizophrenia first undergo an 8-week pharmacological optimization phase comparing clozapine alone, clozapine with amisulpride, or clozapine with aripiprazole. Eligible participants then enter a 4-week assessor-blinded neuromodulation phase comparing modified electroconvulsive therapy (MECT) and magnetic seizure therapy (MST). The trial will assess symptom reduction, cognitive safety, and overall tolerability to guide future treatment decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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:

  1. Participants who have previously received clozapine treatment and are hospitalized due to symptom exacerbation or clinical worsening.
  2. 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 Criteria:

* 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.

Where it's running

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

Study contacts

• Principal investigator: DengTang Liu — Shanghai Mental Health Center
• Study coordinator: DengTang Liu, MD, PhD
• Email: erliu110@126.com
• Phone: +86-18017311138

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nitraria Retusa Infusion for Clozapine-Related Metabolic Side Effects in Treatment-Resistant Schizophrenia

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• Cognitive Behavioral Therapy for Sleep Issues in Schizophrenia

  This study tests if a special type of therapy for sleep problems can help people with schizophrenia who have trouble sleeping feel better and improve their overall quality of life.

  Recruiting Copenhagen University Hospital, Hvidovre · Glostrup, Denmark · NCT06749444

• Magnetic seizure therapy versus electroconvulsive therapy for treatment‑resistant schizophrenia

  This trial will test whether magnetic seizure therapy works as well as a specific form of electroconvulsive therapy for adults whose schizophrenia or schizoaffective disorder has not improved with medications.

  Recruiting at 2 sites Centre for Addiction and Mental Health · Vancouver, British Columbia and 1 other locations · NCT06672588

• Using maintenance electroconvulsive therapy for treatment-resistant schizophrenia

  This study is testing if adding maintenance electroconvulsive therapy to clozapine can help people with treatment-resistant schizophrenia stay well longer and improve their quality of life.

  Recruiting Central Institute of Mental Health, Mannheim · Aachen and 13 other locations · NCT06456983

• Reducing auditory-verbal hallucinations in schizophrenia using brain stimulation

  This study is testing a new brain stimulation method to see if it can help people with schizophrenia who hear voices and haven't found relief with regular medications.

  Recruiting Centre Hospitalier St Anne · Paris · NCT06361160

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.