Adjunctive iTBS for First-Episode Schizophrenia

NCT07116850 | Completed

• 1 other identifier: 2023S00450
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia Disorder

Outcome Measures

Primary Outcomes (1)

• Total Effective Rate based on PANSS

  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).

  3 Months

Secondary Outcomes (3)

• Change in Serum Glial Cell Line-Derived Neurotrophic Factor (GDNF) Level

  Baseline, 3 Months

• Change in Serum Creatine Kinase-MB (CK-MB) Level

  Baseline, 3 Months

• Change in Serum Dehydroepiandrosterone Sulfate (DHEA-S) Level

  Baseline, 3 Months

Study Arms (2)

Experimental: Adjunctive iTBS Group

EXPERIMENTAL

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).

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

Active Comparator: Control Group

ACTIVE COMPARATOR

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.

Drug: Risperidone; Behavioral: Cognitive Behavioral Therapy (CBT)

Interventions

Intermittent Theta-Burst Stimulation (iTBS) DEVICE

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.

Experimental: Adjunctive iTBS Group

Risperidone DRUG

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.

Active Comparator: Control Group; Experimental: Adjunctive iTBS Group

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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; Experimental: Adjunctive iTBS Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 12, 2025
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

CN (1)