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NCT Number: NCT07116850

Adjunctive iTBS for First-Episode Schizophrenia

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.

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Key information

Conditions

Schizophrenia Disorder Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Total Effective Rate based on PANSS

    Time frame: 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 outcomes

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

    Time frame: Baseline, 3 Months

    Change in serum concentration of GDNF from baseline.

  2. Change in Serum Creatine Kinase-MB (CK-MB) Level

    Time frame: Baseline, 3 Months

    Change in serum concentration of CK-MB from baseline.

  3. Change in Serum Dehydroepiandrosterone Sulfate (DHEA-S) Level

    Time frame: Baseline, 3 Months

    Change in serum concentration of DHEA-S from baseline.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

Adjunctive Intermittent Theta-Burst Stimulation for First-Episode Schizophrenia: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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