Schizophrenia, Tardive Dyskinesia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years, inclusive, regardless of sex; 2. Diagnosed by the study physician as experiencing an episode of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), whether first episode or recurrent; 3. A medical history of treatment with a dopamine receptor blocking agent for at least 3 months; 4. Scores on the Abnormal Involuntary Movement Scale (AIMS) meet the criterion of at least two items rated >= 2 or at least one item rated >= 3; 5. No change in schizophrenia medication regimen within 30 days prior to signing the informed consent form until the trial period; 6. The patient's involuntary movements are not caused by neurological diseases such as Parkinson's disease, Huntington's chorea, or oral and facial abnormalities due to edentulism; 7. Possesses a certain level of listening, speaking, reading, writing, and comprehension skills, capable of completing study assessments; 8. Based on the judgment of the research physician, the subject understands the purpose and procedures of the study, is able to comply with the study protocol requirements, and can sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of other psychiatric disorders, neurological diseases, or substance abuse that, in the researcher's judgment, may affect the assessment of the study's efficacy; 2. Individuals with a history of epilepsy or previous seizure episodes; 3. Individuals with metal foreign objects in the cranial cavity or metal implants in the heart; 4. Individuals with organic brain disease, a history of severe head injury, or previous head surgeries; 5. Individuals who have undergone electroconvulsive therapy (ECT) or other physical treatments (e.g., transcranial magnetic stimulation, transcranial electrical stimulation, etc.) within the past 30 days; 6. Individuals with a HAMD (Hamilton Depression Rating Scale) suicide item score of 3 or higher; 7. Individuals currently pregnant, breastfeeding, or planning to conceive during the trial period; 8. Individuals currently participating in other interventional clinical trials; 9. Any other situation deemed unsuitable for participation in the study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms of tardive dyskinesia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;Quality of life;Positive and Negative Syndrome;Functional magnetic resonance imaging (fMRI);Changes in electroencephalogram (EEG) signals;Cognitive function;Antipsychotic-induced extrapyramidal symptoms (EPS);Depression symptom;Anxiety symptom;Degree of akathisia severity; | — |
Countries
China
Contacts
Tianjin Anding Hospital