Adjunctive iTBS for First-Episode Schizophrenia

Hebei Medical University

Status: Completed

Conditions: Schizophrenia Disorder

Treatments: Drug: Risperidone; Behavioral: Cognitive Behavioral Therapy (CBT); Device: Intermittent Theta-Burst Stimulation (iTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07116850

2023S00450

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Experimental: Adjunctive iTBS Group

Experimental group

Description:

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).

Treatment:

Device: Intermittent Theta-Burst Stimulation (iTBS)

Behavioral: Cognitive Behavioral Therapy (CBT)

Drug: Risperidone

Active Comparator: Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

Drug: Risperidone