cTBS on First-episode Drug Naive Patients With Schizophrenia

NCT05086133 | Unknown

• 1 other identifier: WU2021TBS
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression. 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

Schizophrenia

Outcome Measures

Primary Outcomes (4)

• Three-Factor Eating Questionnaire

  min value 21, max value 84. The higher scores mean more unhealthy eating behavior.

  Change from Baseline to 6days and 36days

• MCCB

  The MATRICS™ Consensus Cognitive Battery

  Change from Baseline to 6days and 36days

• The positive and negative syndrome scale

  min score 30, max score 210. The higher score means more severe symptoms.

  Change from Baseline to 6days and 36days

• BMI

  body mass index

  Change from Baseline to 6days and 36days

Secondary Outcomes (6)

• Resting EEG

  Change from Baseline to 6days and 36days

• fasting glucose

  Change from Baseline to 6days and 36days

• Triglyceride

  Change from Baseline to 6days and 36days

• Total Cholesterol

  Change from Baseline to 6days and 36days

• Low Density Lipoprotein

  Change from Baseline to 6days and 36days

Study Arms (2)

cTBS stimulation

EXPERIMENTAL

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.

Device: transcranial magnetic stimulation

Sham stimulation

SHAM COMPARATOR

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.

Device: sham stimulation

Interventions

transcranial magnetic stimulation DEVICE

transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total.

cTBS stimulation

sham stimulation DEVICE

TMS coil vertical to the brain surface, with same protocol as cTBS

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with schizophrenia in accordance with DSM-5
• The course of the disease less then 2 years
• Accepting antipsychotics treatment for less then 2 months

You may not qualify if:

• Diagnosed with other mental disease in accordance with DSM-5
• 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

Sponsors & Collaborators

• Central South University: lead
• Shanghai Mental Health Center: collaborator

Study Sites (1)

Central South University

Changsha, Hunan, 410000, China

Location

Related Publications (2)

• 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.

  PMID: 38272892 DERIVED

• 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.

  PMID: 37921353 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants will be randomized into experimental group or sham group by a predetermined randomization table. The participants, care provider, investigators and outcomes assessor will be blind to the grouping. The physician who perform the TMS intervention is not blind to the grouping.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1 group for intervention and 1 group for sham stimulation

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 20, 2021
• Study Start: November 20, 2021
• Primary Completion: November 15, 2022
• Study Completion: June 1, 2023
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)