Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2024-01-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental: Adjunctive iTBS Group
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).
Intermittent Theta-Burst Stimulation (iTBS)
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.
Risperidone
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.
Cognitive 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.
Active Comparator: Control Group
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.
Risperidone
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.
Cognitive 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.
Interventions
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Intermittent Theta-Burst Stimulation (iTBS)
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.
Risperidone
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.
Cognitive 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
45 Years
ALL
No
Sponsors
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The First Hospital of Hebei Medical University
OTHER
Responsible Party
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Jiali Cui
Principal investigator
Locations
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The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Countries
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Other Identifiers
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2023S00450
Identifier Type: -
Identifier Source: org_study_id
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