Schizophrenia Disorder
Conditions
Brief 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.
Detailed description
Schizophrenia is a severe mental disorder often treated with atypical antipsychotics like risperidone. However, pharmacotherapy alone has limited efficacy, especially for negative symptoms and cognitive deficits. Intermittent theta-burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation (rTMS), and cognitive behavioral therapy (CBT) are promising adjunctive treatments. This study was designed to prospectively evaluate the synergistic effects of a tripartite therapy. One hundred patients with first-episode schizophrenia were randomized to either an experimental group (iTBS + risperidone + CBT) or an active control group (risperidone + CBT). The primary objective was to assess the difference in clinical effective rate at 3 months, measured by the Positive and Negative Syndrome Scale (PANSS). Secondary objectives included evaluating changes in cognitive function (using subtests from the MATRICS Consensus Cognitive Battery), serum levels of potential biomarkers (GDNF, CK-MB, DHEA-S), and safety. The study aims to provide evidence for integrating iTBS into a multimodal treatment strategy for early-stage schizophrenia.
Interventions
Stimulation delivered using a Magstim RAPID2 stimulator. The target was the left DLPFC (F3 position). The protocol consisted of 20 sessions (5 days/week for 4 weeks) at 100% of the individual's motor threshold (MT), with each session delivering 2400 pulses.
DRUGRisperidone
Oral risperidone (Jiangsu Enhua Pharmaceutical Co., Ltd.) initiated at 1 mg/day and flexibly titrated based on efficacy and tolerability to a maximum of 6 mg/day.
BEHAVIORALCognitive Behavioral Therapy (CBT)
Manualized CBT administered twice weekly for 12 weeks. The therapy comprised an initial individual phase (4 weeks) focusing on psychoeducation and a subsequent group phase (8 weeks) targeting social and emotional skills.
Sponsors
The First Hospital of Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Effective Rate based on PANSS | 3 Months | Clinical efficacy defined by the total effective rate based on the Positive and Negative Syndrome Scale (PANSS). The reduction rate is calculated as: (Baseline PANSS - Post-treatment PANSS) / (Baseline PANSS - 30). Total effective rate is the sum of participants achieving Cure (≥75% reduction), Marked Improvement (26%-74% reduction), or Effective (≥25% reduction). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Glial Cell Line-Derived Neurotrophic Factor (GDNF) Level | Baseline, 3 Months | Change in serum concentration of GDNF from baseline. |
| Change in Serum Creatine Kinase-MB (CK-MB) Level | Baseline, 3 Months | Change in serum concentration of CK-MB from baseline. |
| Change in Serum Dehydroepiandrosterone Sulfate (DHEA-S) Level | Baseline, 3 Months | Change in serum concentration of DHEA-S from baseline. |
Countries
China
Outcome results
None listed