cTBS on First-episode Drug Naive Patients With Schizophrenia
NCT ID: NCT05086133
Last Updated: 2022-11-17
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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UNKNOWN
NA
44 participants
INTERVENTIONAL
2021-11-20
2023-06-01
Brief Summary
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Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.
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Detailed Description
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Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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cTBS stimulation
The participants randomized into experimental group will receive cTBS stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.
transcranial magnetic stimulation
transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total.
Sham stimulation
The participants randomized into experimental group will receive sham stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.
sham stimulation
TMS coil vertical to the brain surface, with same protocol as cTBS
Interventions
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transcranial magnetic stimulation
transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total.
sham stimulation
TMS coil vertical to the brain surface, with same protocol as cTBS
Eligibility Criteria
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Inclusion Criteria
* The course of the disease less then 2 years
* Accepting antipsychotics treatment for less then 2 months
Exclusion Criteria
* Comorbid with other severe physiological disease
* Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before
* Drug or alcohol abuse
* Pregnant or lactating Contraindication to rTMS
18 Years
40 Years
ALL
No
Sponsors
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Shanghai Mental Health Center
OTHER
Central South University
OTHER
Responsible Party
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Renrong Wu
Professor
Locations
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Central South University
Changsha, Hunan, China
Countries
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References
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Kang D, Song C, Peng X, Yu G, Yang Y, Chen C, Long Y, Shao P, Wu R. The effect of continuous theta burst stimulation on antipsychotic-induced weight gain in first-episode drug-naive individuals with schizophrenia: a double-blind, randomized, sham-controlled feasibility trial. Transl Psychiatry. 2024 Jan 25;14(1):61. doi: 10.1038/s41398-024-02770-w.
Kang D, Zhang Y, Wu G, Song C, Peng X, Long Y, Yu G, Tang H, Gui Y, Wang Q, Yuan T, Wu R. The Effect of Accelerated Continuous Theta Burst Stimulation on Weight Loss in Overweight Individuals With Schizophrenia: A Double-Blind, Randomized, Sham-Controlled Clinical Trial. Schizophr Bull. 2024 Apr 30;50(3):589-599. doi: 10.1093/schbul/sbad144.
Other Identifiers
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WU2021TBS
Identifier Type: -
Identifier Source: org_study_id
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