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 range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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