Adjunctive iTBS for First-Episode Schizophrenia (NCT07116850) | Clinical Trial Compass
CompletedNot Applicable
Adjunctive iTBS for First-Episode Schizophrenia
China100 participantsStarted 2024-01-01
Plain-language summary
This prospective, randomized, assessor-blinded study investigates the efficacy and safety of adding intermittent theta-burst stimulation (iTBS) to a standard treatment of risperidone and cognitive behavioral therapy (CBT) for patients with first-episode schizophrenia. The study aims to compare clinical symptom improvement, cognitive function changes, and levels of serum biomarkers (GDNF, CK-MB, DHEA-S) between a group receiving the combined therapy (iTBS+risperidone+CBT) and a control group receiving standard therapy (risperidone+CBT) over a 3-month period.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Diagnosis of first-episode schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
* Age between 18 and 45 years.
* No prior antipsychotic treatment or a washout period of at least 4 weeks for any previous psychotropic medications.
* No contraindications to risperidone or iTBS.
* Educational level of junior high school or above, capable of understanding and completing study assessments.
Exclusion Criteria:
* Comorbid severe psychiatric disorders or significant organic brain disease.
* Pregnancy or lactation.
* Severe alcohol or substance dependence.
* Concurrent use of medications known to interact significantly with risperidone or affect cognitive function.
* Conditions that could interfere with cognitive assessment.
* Endocrine disorders, nutritional diseases, or epilepsy.
* History of cranial surgery or presence of metal implants in the head.
* Presence of biomedical devices (e.g., cardiac pacemakers).
What they're measuring
1
Total Effective Rate based on PANSS
Timeframe: 3 Months
Trial details
NCT IDNCT07116850
SponsorThe First Hospital of Hebei Medical University