Schizophrenia DisorderNCT07116850
Adjunctive iTBS for First-Episode Schizophrenia
A study testing Intermittent Theta-Burst Stimulation (iTBS), Risperidone and Cognitive Behavioral Therapy (CBT) in people with Schizophrenia Disorder, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia Disorder
- What is being tested?
- Intermittent Theta-Burst Stimulation (iTBS), Risperidone and Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: Adjunctive Intermittent Theta-Burst Stimulation for First-Episode Schizophrenia: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Schizophrenia Disorder
- Being tested
- Intermittent Theta-Burst Stimulation (iTBS), Risperidone, Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
RisperidoneDrug
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Risperidone; Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 Months
Secondary outcomes (3)
Change in Serum Glial Cell Line-Derived Neurotrophic Factor (GDNF) Level
Change in serum concentration of GDNF from baseline.
Measured: Baseline, 3 Months
Change in Serum Creatine Kinase-MB (CK-MB) Level
Change in serum concentration of CK-MB from baseline.
Measured: Baseline, 3 Months
Change in Serum Dehydroepiandrosterone Sulfate (DHEA-S) Level
Change in serum concentration of DHEA-S from baseline.
Measured: Baseline, 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiali Cui, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116850
- Sponsor's protocol ID
- 2023S00450
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Intermittent Theta-Burst Stimulation for First-Episode Schizophrenia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07116850
- Acronym / sponsor ID
- 2023S00450
- Conditions
- Schizophrenia Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Adjunctive iTBS Group | Experimental | Device: Intermittent Theta-Burst Stimulation (iTBS), Drug: Risperidone, Behavioral: 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 | Active comparator | Drug: Risperidone, Behavioral: 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Experimental: Adjunctive iTBS Group |
| RisperidoneOral 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. | Drug | Active Comparator: Control Group, Experimental: Adjunctive iTBS Group |
| 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. | Behavioural | Active Comparator: Control Group, Experimental: Adjunctive iTBS Group |
Primary outcome
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).
3 secondary outcomes
Change in Serum Glial Cell Line-Derived Neurotrophic Factor (GDNF) Level
Time frame: Baseline, 3 Months
Change in Serum Creatine Kinase-MB (CK-MB) Level
Time frame: Baseline, 3 Months
Change in Serum Dehydroepiandrosterone Sulfate (DHEA-S) Level
Time frame: Baseline, 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Theta-Burst Stimulation (iTBS), Risperidone and Cognitive Behavioral Therapy (CBT) in people with Schizophrenia Disorder, run by The First Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Effective Rate based on PANSS (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025; AzTrials last refreshed its copy on 28 Oct 2026.