NCT07116850Completed
Adjunctive iTBS for First-Episode Schizophrenia
Adjunctive Intermittent Theta-Burst Stimulation for First-Episode Schizophrenia: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 12 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 7 Aug 2025
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- The First Hospital of Hebei Medical University
- Diseases
- Schizophrenia
- NCT number
- NCT07116850
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 1 Jan 2024 to the primary completion date, 31 Dec 2024
- 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of medications known to interact significantly with risperidone or affect cognitive function.
Other illness
- Comorbid severe psychiatric disorders or significant organic brain disease.
- 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).
Other
- Pregnancy or lactation.
- Severe alcohol or substance dependence.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.