Adjunctive iTBS for First-Episode Schizophrenia
- Conditions
- Schizophrenia Disorder
- Interventions
- Device: Intermittent Theta-Burst Stimulation (iTBS)Behavioral: Cognitive Behavioral Therapy (CBT)
- Registration Number
- NCT07116850
- Lead Sponsor
- The First Hospital of Hebei Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Adjunctive iTBS Group Intermittent Theta-Burst Stimulation (iTBS) Participants (n=50) received risperidone (initiated at 1 mg/day and flexibly titrated to a maximum of 6 mg/day) and manualized Cognitive Behavioral Therapy (CBT) administered twice weekly for 12 weeks. In addition, they received active intermittent theta-burst stimulation (iTBS) for 20 sessions (5 days/week for 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC). Experimental: Adjunctive iTBS Group Risperidone Participants (n=50) received risperidone (initiated at 1 mg/day and flexibly titrated to a maximum of 6 mg/day) and manualized Cognitive Behavioral Therapy (CBT) administered twice weekly for 12 weeks. In addition, they received active intermittent theta-burst stimulation (iTBS) for 20 sessions (5 days/week for 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC). Experimental: Adjunctive iTBS Group Cognitive Behavioral Therapy (CBT) Participants (n=50) received risperidone (initiated at 1 mg/day and flexibly titrated to a maximum of 6 mg/day) and manualized Cognitive Behavioral Therapy (CBT) administered twice weekly for 12 weeks. In addition, they received active intermittent theta-burst stimulation (iTBS) for 20 sessions (5 days/week for 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC). Active Comparator: Control Group Risperidone Participants (n=50) received an identical regimen of risperidone (initiated at 1 mg/day and flexibly titrated to a maximum of 6 mg/day) and manualized Cognitive Behavioral Therapy (CBT) administered twice weekly for 12 weeks, without iTBS. Active Comparator: Control Group Cognitive Behavioral Therapy (CBT) Participants (n=50) received an identical regimen of risperidone (initiated at 1 mg/day and flexibly titrated to a maximum of 6 mg/day) and manualized Cognitive Behavioral Therapy (CBT) administered twice weekly for 12 weeks, without iTBS.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The First Hospital of Hebei Medical University🇨🇳Shijiazhuang, Hebei, China