Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-27 @ 6:36 AM
Study NCT ID:
NCT07116850
Status:
COMPLETED
Last Update Posted:
2025-08-12
First Post:
2025-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive iTBS for First-Episode Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-08-07', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Effective Rate based on PANSS', 'timeFrame': '3 Months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Change in Serum Glial Cell Line-Derived Neurotrophic Factor (GDNF) Level', 'timeFrame': 'Baseline, 3 Months', 'description': 'Change in serum concentration of GDNF from baseline.'}, {'measure': 'Change in Serum Creatine Kinase-MB (CK-MB) Level', 'timeFrame': 'Baseline, 3 Months', 'description': 'Change in serum concentration of CK-MB from baseline.'}, {'measure': 'Change in Serum Dehydroepiandrosterone Sulfate (DHEA-S) Level', 'timeFrame': 'Baseline, 3 Months', 'description': 'Change in serum concentration of DHEA-S from baseline.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of first-episode schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).\n* Age between 18 and 45 years.\n* No prior antipsychotic treatment or a washout period of at least 4 weeks for any previous psychotropic medications.\n* No contraindications to risperidone or iTBS.\n* Educational level of junior high school or above, capable of understanding and completing study assessments.\n\nExclusion Criteria:\n\n* Comorbid severe psychiatric disorders or significant organic brain disease.\n* Pregnancy or lactation.\n* Severe alcohol or substance dependence.\n* Concurrent use of medications known to interact significantly with risperidone or affect cognitive function.\n* Conditions that could interfere with cognitive assessment.\n* Endocrine disorders, nutritional diseases, or epilepsy.\n* History of cranial surgery or presence of metal implants in the head.\n* Presence of biomedical devices (e.g., cardiac pacemakers).'}, 'identificationModule': {'nctId': 'NCT07116850', 'briefTitle': 'Adjunctive iTBS for First-Episode Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Hebei Medical University'}, 'officialTitle': 'Adjunctive Intermittent Theta-Burst Stimulation for First-Episode Schizophrenia: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2023S00450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Adjunctive iTBS 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).', 'interventionNames': ['Device: Intermittent Theta-Burst Stimulation (iTBS)', 'Drug: Risperidone', 'Behavioral: Cognitive Behavioral Therapy (CBT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Control 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.', 'interventionNames': ['Drug: Risperidone', 'Behavioral: Cognitive Behavioral Therapy (CBT)']}], 'interventions': [{'name': 'Intermittent Theta-Burst Stimulation (iTBS)', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['Experimental: Adjunctive iTBS Group']}, {'name': 'Risperidone', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Active Comparator: Control Group', 'Experimental: Adjunctive iTBS Group']}, {'name': 'Cognitive Behavioral Therapy (CBT)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Active Comparator: Control Group', 'Experimental: Adjunctive iTBS Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Hebei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jiali Cui', 'investigatorAffiliation': 'The First Hospital of Hebei Medical University'}}}}